CARDIOSAVE
Report
- Report Number
- 2249723-2018-00447
- Event Type
- Death
- Date Received
- March 21, 2018
- Date of Event
- February 22, 2018
- Report Date
- April 26, 2018
- Manufacturer
- DATASCOPE MAHWAH
- Product Code
- DSP
- PMA / PMN Number
- K112372
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS IABP UNIT CANNOT BE REVIEWED PER THE SOP SINCE THE SERIAL NUMBER FOR THE UNIT WAS NOT PROVIDED. THERE HAS BEEN NO REPORTED MALFUNCTION OF THE IABP, AND THE CUSTOMER HAS NOT REQUESTED GETINGE TO EVALUATE THE IABP. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
THE CUSTOMER PROVIDED ADDITIONAL INFORMATION WHICH HAS BEEN UPDATED IN FIELD AND DIFFERENT BIOGRAPHIC INFORMATION ON THE PATIENT WHICH HAS BEEN UPDATED.
THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT REVIEWED AS NO PRODUCT FAILURE MODE WAS REPORTED FOR REVIEW. THE CUSTOMER HAS ADVISED THAT THERE WAS NO MALFUNCTION OF THE IABP, THAT NO EVALUATION AND/OR REPAIRS WERE NECESSARY AND THAT THE IABP IS IN CLINICAL USE WITH NO ISSUES. NO FURTHER INVESTIGATION IS REQUIRED. UPDATED FIELDS: (CATALOG # AND SERIAL (B)(4)).
CORRECTED FIELD: (SENTENCE IN EVENT DESCRIPTION CORRECTED TO INCLUDE THE WORD "OCCLUSION"). HE WAS EMERGENTLY TAKEN TO THE CATHETER LAB WHERE HE UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE CIRCULATION (CIRC) WITH 2 DRUG-ELUTING STENTS (DESS) AND ALSO HAD WHAT APPEARED TO BE A CHRONIC TOTAL OCCLUSION OF RIGHT CORONARY ARTERY (RCA).
THE CUSTOMER REPORTED THAT A PATIENT DEATH OCCURRED THAT IS POSSIBLY BEING CONSIDERED A COMPLICATION FROM AN UNKNOWN GETINGE INTRA-AORTIC BALLOON PUMP (IABP). THE PATIENT PRESENTED TO THE ED POV EMERGENCY DEPARTMENT FROM PRIVATELY OWNED VEHICLE (ED POV) AS A ST ELEVATION MYOCARDIAL INFARCTION (STEMI) IN CARDIOGENIC SHOCK. HE WAS EMERGENTLY TAKEN TO THE CATHETER LAB WHERE HE UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE CIRCULATION (CIRC) WITH 2 DRUG-ELUTING STENTS (DESS) AND ALSO HAD WHAT APPEARED TO BE A CHRONIC TOTAL RIGHT CORONARY ARTERY (RCA). AN ATTEMPT TO OPEN THE RCA WAS MADE BUT WAS NOT SUCCESSFUL. THE PATIENT WAS HYPOTENSIVE THROUGHOUT THE PROCEDURE SO AN INTRA-AORTIC BALLOON PUMP (IABP) WAS PLACED. WHEN THE PATIENT ARRIVED TO THE CORONARY CARE UNIT (CCU) THE NURSE STATES THAT HE WAS COMPLAINING OF ABDOMINAL PAIN WITH NAUSEA AND VOMITING. SHE MEDICATED HIM FOR THIS BUT SYMPTOMS CONTINUED. APPROXIMATELY 3 HOURS AFTER THE IABP WAS PLACED HE WAS SENT TO COMMUTED TOMOGRAPHY (CT). THE CT IMAGES SHOWED THAT THE INTRA-AORTIC BALLOON (IAB) WAS IN THE AORTA AND THE OPAQUE TIP WAS LOCATED AT THE LUMBAR VERTEBRAE 3 (L3) LEVEL AND WAS OCCLUDING THE ORIGIN OF THE SUPERIOR MESENTERIC ARTERY (SMA) WITH RESULTANT ISCHEMIC GUT AND DIFFUSE PORTAL AND MESENTERIC VENOUS GAS. THE IAB WAS THEN EMERGENTLY REMOVED BY THE CARDIOLOGIST. APPROXIMATE TIME THE IAB WAS IN THE PATIENT WAS 3.5 HOURS. CUSTOMER ADVISE THAT THE CASE IS BEING REVIEWED AS A POTENTIAL DEVICE RELATED DEATH, AND HAVE NOTED THAT THERE ARE OBVIOUSLY MANY QUESTIONS ABOUT PLACEMENT OF THE DEVICE, AND THAT IS A STRUGGLE BECAUSE THERE ARE NO POST PLACEMENT CINE SHOTS FOR VALIDATION AND VISUALIZATION PLACEMENT., AND THAT THE MEDICAL DOCTOR (MD) DID LOOK, BUT DID NOT SEE THE IMAGE. THERE WAS A POST PROCEDURE CHEST X-RAY REVEALED THAT THE PROXIMAL TIP OF THE IAB WAS ¿SEEN ON THE INFERIOR ASPECT OF THE AORTIC ARCH¿. THIS WAS TAKEN 1.5 HOURS PRIOR TO THE CT. ALL REPORTS FROM SURGEON AND INTENSIVIST ARE STATING THAT THE ISCHEMIC BOWL WAS A RESULT OF THE IAB. ON ARRIVAL, THE PATIENT APPEARED TO BE IN ACUTE RENAL FAILURE (NO PRIOR KNOWN HISTORY WITH A CREATINE OF 3.0) WITH ELEVATION OF HIS LIVER ENZYMES AND ELEVATED WHITE BLOOD CELL COUNT. THIS CASE WILL GO THROUGH THE CUSTOMER'S PEER REVIEW PROCESS. THE DATE OF THE DEATH IS UNKNOWN. IN ADDITION, THERE HAS BEEN NO REPORTED MALFUNCTION OF THE UNKNOWN IABP.
THE CUSTOMER REPORTED THAT A PATIENT DEATH OCCURRED THAT IS POSSIBLY BEING CONSIDERED A COMPLICATION FROM AN UNKNOWN GETINGE INTRA-AORTIC BALLOON PUMP (IABP). THE PATIENT PRESENTED TO THE ED POV EMERGENCY DEPARTMENT FROM PRIVATELY OWNED VEHICLE (ED POV) AS A ST ELEVATION MYOCARDIAL INFARCTION (STEMI) IN CARDIOGENIC SHOCK. HE WAS EMERGENTLY TAKEN TO THE CATHETER LAB WHERE HE UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE CIRCULATION (CIRC) WITH 2 DRUG-ELUTING STENTS (DESS) AND ALSO HAD WHAT APPEARED TO BE A CHRONIC TOTAL RIGHT CORONARY ARTERY (RCA). AN ATTEMPT TO OPEN THE RCA WAS MADE BUT WAS NOT SUCCESSFUL. THE PATIENT WAS HYPOTENSIVE THROUGHOUT THE PROCEDURE SO AN INTRA-AORTIC BALLOON PUMP (IABP) WAS PLACED. WHEN THE PATIENT ARRIVED TO THE CORONARY CARE UNIT (CCU) THE NURSE STATES THAT HE WAS COMPLAINING OF ABDOMINAL PAIN WITH NAUSEA AND VOMITING. SHE MEDICATED HIM FOR THIS BUT SYMPTOMS CONTINUED. APPROXIMATELY 3 HOURS AFTER THE IABP WAS PLACED HE WAS SENT TO COMMUTED TOMOGRAPHY (CT). THE CT IMAGES SHOWED THAT THE INTRA-AORTIC BALLOON (IAB) WAS IN THE AORTA AND THE OPAQUE TIP WAS LOCATED AT THE LUMBAR VERTEBRAE 3 (L3) LEVEL AND WAS OCCLUDING THE ORIGIN OF THE SUPERIOR MESENTERIC ARTERY (SMA) WITH RESULTANT ISCHEMIC GUT AND DIFFUSE PORTAL AND MESENTERIC VENOUS GAS. THE IAB WAS THEN EMERGENTLY REMOVED BY THE CARDIOLOGIST. APPROXIMATE TIME THE IAB WAS IN THE PATIENT WAS 3.5 HOURS. CUSTOMER ADVISE THAT THE CASE IS BEING REVIEWED AS A POTENTIAL DEVICE RELATED DEATH, AND HAVE NOTED THAT THERE ARE OBVIOUSLY MANY QUESTIONS ABOUT PLACEMENT OF THE DEVICE, AND THAT IS A STRUGGLE BECAUSE THERE ARE NO POST PLACEMENT CINE SHOTS FOR VALIDATION AND VISUALIZATION PLACEMENT., AND THAT THE MEDICAL DOCTOR (MD) DID LOOK, BUT DID NOT SEE THE IMAGE. THERE WAS A POST PROCEDURE CHEST X-RAY REVEALED THAT THE PROXIMAL TIP OF THE IAB WAS ¿SEEN ON THE INFERIOR ASPECT OF THE AORTIC ARCH¿. THIS WAS TAKEN 1.5 HOURS PRIOR TO THE CT. ALL REPORTS FROM SURGEON AND INTENSIVIST ARE STATING THAT THE ISCHEMIC BOWL WAS A RESULT OF THE IAB. ON ARRIVAL, THE PATIENT APPEARED TO BE IN ACUTE RENAL FAILURE (NO PRIOR KNOWN HISTORY WITH A CREATINE OF 3.0) WITH ELEVATION OF HIS LIVER ENZYMES AND ELEVATED WHITE BLOOD CELL COUNT. THIS CASE WILL GO THROUGH THE CUSTOMER'S PEER REVIEW PROCESS. IN ADDITION, THERE HAS BEEN NO REPORTED MALFUNCTION OF THE UNKNOWN IABP. UPDATED INFORMATION FROM CUSTOMER: PATIENT PRESENTED TO EMERGENCY DEPARTMENT ON (B)(6) 2018 WITH A ST ELEVATION MYOCARDIAL INFARCTION (STEMI). PATIENT WAS BROUGHT EMERGENTLY TO CATH LAB AT 1317. PATIENT ARRIVED WITH BP OF 100 SYSTOLIC, AND DURING THE COURSE OF INTERVENTION , THE BP DROPPED AND PATIENT WAS PLACED ON PRESSORS AND IABP WAS PLACED UNDER FLUOROSCOPY AT AROUND 1457 AT A 1:1 SETTING. POSITION WAS VERIFIED BY PHYSICIAN; HOWEVER, NO IMAGES WERE SAVED. INTRA AORTIC BALLOON (IAB) WAS SUTURED IN PLACE AND SECURED WITH STAT LOCKS. UPON ARRIVAL TO ICU, THE PATIENT BECAME NAUSEOUS AND BEGAN HAVING ABDOMINAL PAIN. PATIENT HAD CT OF ABDOMEN AND PELVIS AT AROUND 1800 WHICH REPORTED BALLOON TIP AT THE LEVEL OF L3. THE CT SHOWED TIP OF BALLOON WAS OCCLUDING SUPERIOR MESENTERIC ARTERY (SMA) WITH ISCHEMIC GUT AND DIFFUSE PORTAL AND MESENTERIC VENOUS GAS. THE CARDIOLOGIST WAS CALLED AND THE IAB WAS REMOVED BY PHYSICIAN AT APPROXIMATELY 1945 ON (B)(6) 2018. CENTRAL LINE WAS PLACED AND PATIENT WAS INITIATED ON CVHD. PATIENT'S CONDITION CONTINUED TO DETERIORATE AND FAMILY MADE PATIENT DNR. THE PATIENT WAS EXTUBATED PER THE FAMILY'S REQUEST AND EXPIRED ON (B)(6) 2018. INDICATIONS FOR IABP THERAPY WAS CARDIOGENIC SHOCK.
THE CUSTOMER REPORTED THAT A PATIENT DEATH OCCURRED THAT IS POSSIBLY BEING CONSIDERED A COMPLICATION FROM A CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP). THE PATIENT PRESENTED TO THE ED POV EMERGENCY DEPARTMENT FROM PRIVATELY OWNED VEHICLE (ED POV) AS A ST ELEVATION MYOCARDIAL INFARCTION (STEMI) IN CARDIOGENIC SHOCK. HE WAS EMERGENTLY TAKEN TO THE CATHETER LAB WHERE HE UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE CIRCULATION (CIRC) WITH 2 DRUG-ELUTING STENTS (DESS) AND ALSO HAD WHAT APPEARED TO BE A CHRONIC TOTAL RIGHT CORONARY ARTERY (RCA). AN ATTEMPT TO OPEN THE RCA WAS MADE BUT WAS NOT SUCCESSFUL. THE PATIENT WAS HYPOTENSIVE THROUGHOUT THE PROCEDURE SO AN INTRA-AORTIC BALLOON PUMP (IABP) WAS PLACED. WHEN THE PATIENT ARRIVED TO THE CORONARY CARE UNIT (CCU) THE NURSE STATES THAT HE WAS COMPLAINING OF ABDOMINAL PAIN WITH NAUSEA AND VOMITING. SHE MEDICATED HIM FOR THIS BUT SYMPTOMS CONTINUED. APPROXIMATELY 3 HOURS AFTER THE IABP WAS PLACED HE WAS SENT TO COMMUTED TOMOGRAPHY (CT). THE CT IMAGES SHOWED THAT THE INTRA-AORTIC BALLOON (IAB) WAS IN THE AORTA AND THE OPAQUE TIP WAS LOCATED AT THE LUMBAR VERTEBRAE 3 (L3) LEVEL AND WAS OCCLUDING THE ORIGIN OF THE SUPERIOR MESENTERIC ARTERY (SMA) WITH RESULTANT ISCHEMIC GUT AND DIFFUSE PORTAL AND MESENTERIC VENOUS GAS. THE IAB WAS THEN EMERGENTLY REMOVED BY THE CARDIOLOGIST. APPROXIMATE TIME THE IAB WAS IN THE PATIENT WAS 3.5 HOURS. CUSTOMER ADVISE THAT THE CASE IS BEING REVIEWED AS A POTENTIAL DEVICE RELATED DEATH, AND HAVE NOTED THAT THERE ARE OBVIOUSLY MANY QUESTIONS ABOUT PLACEMENT OF THE DEVICE, AND THAT IS A STRUGGLE BECAUSE THERE ARE NO POST PLACEMENT CINE SHOTS FOR VALIDATION AND VISUALIZATION PLACEMENT., AND THAT THE MEDICAL DOCTOR (MD) DID LOOK, BUT DID NOT SEE THE IMAGE. THERE WAS A POST PROCEDURE CHEST X-RAY REVEALED THAT THE PROXIMAL TIP OF THE IAB WAS ¿SEEN ON THE INFERIOR ASPECT OF THE AORTIC ARCH¿. THIS WAS TAKEN 1.5 HOURS PRIOR TO THE CT. ALL REPORTS FROM SURGEON AND INTENSIVIST ARE STATING THAT THE ISCHEMIC BOWL WAS A RESULT OF THE IAB. ON ARRIVAL, THE PATIENT APPEARED TO BE IN ACUTE RENAL FAILURE (NO PRIOR KNOWN HISTORY WITH A CREATINE OF 3.0) WITH ELEVATION OF HIS LIVER ENZYMES AND ELEVATED WHITE BLOOD CELL COUNT. THIS CASE WILL GO THROUGH THE CUSTOMER'S PEER REVIEW PROCESS. IN ADDITION, THERE HAS BEEN NO REPORTED MALFUNCTION OF THE UNKNOWN IABP. UPDATED INFORMATION FROM CUSTOMER: PATIENT PRESENTED TO EMERGENCY DEPARTMENT ON (B)(6) 2018 WITH A ST ELEVATION MYOCARDIAL INFARCTION (STEMI). PATIENT WAS BROUGHT EMERGENTLY TO CATH LAB AT 1317. PATIENT ARRIVED WITH BP OF 100 SYSTOLIC, AND DURING THE COURSE OF INTERVENTION , THE BP DROPPED AND PATIENT WAS PLACED ON PRESSORS AND IABP WAS PLACED UNDER FLUOROSCOPY AT AROUND 1457 AT A 1:1 SETTING. POSITION WAS VERIFIED BY PHYSICIAN; HOWEVER, NO IMAGES WERE SAVED. INTRA AORTIC BALLOON (IAB) WAS SUTURED IN PLACE AND SECURED WITH STAT LOCKS. UPON ARRIVAL TO ICU, THE PATIENT BECAME NAUSEOUS AND BEGAN HAVING ABDOMINAL PAIN. PATIENT HAD CT OF ABDOMEN AND PELVIS AT AROUND 1800 WHICH REPORTED BALLOON TIP AT THE LEVEL OF L3. THE CT SHOWED TIP OF BALLOON WAS OCCLUDING SUPERIOR MESENTERIC ARTERY (SMA) WITH ISCHEMIC GUT AND DIFFUSE PORTAL AND MESENTERIC VENOUS GAS. THE CARDIOLOGIST WAS CALLED AND THE IAB WAS REMOVED BY PHYSICIAN AT APPROXIMATELY 1945 ON (B)(6) 2018. CENTRAL LINE WAS PLACED AND PATIENT WAS INITIATED ON CVHD. PATIENT'S CONDITION CONTINUED TO DETERIORATE AND FAMILY MADE PATIENT DNR. THE PATIENT WAS EXTUBATED PER THE FAMILY'S REQUEST AND EXPIRED ON (B)(6) 2018. INDICATIONS FOR IABP THERAPY WAS CARDIOGENIC SHOCK.
THE CUSTOMER REPORTED THAT A PATIENT DEATH OCCURRED THAT IS POSSIBLY BEING CONSIDERED A COMPLICATION FROM A CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP). THE PATIENT PRESENTED TO THE ED POV EMERGENCY DEPARTMENT FROM PRIVATELY OWNED VEHICLE (ED POV) AS A ST ELEVATION MYOCARDIAL INFARCTION (STEMI) IN CARDIOGENIC SHOCK. HE WAS EMERGENTLY TAKEN TO THE CATHETER LAB WHERE HE UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE CIRCULATION (CIRC) WITH 2 DRUG-ELUTING STENTS (DESS) AND ALSO HAD WHAT APPEARED TO BE A CHRONIC TOTAL OCCLUSION OF RIGHT CORONARY ARTERY (RCA). AN ATTEMPT TO OPEN THE RCA WAS MADE BUT WAS NOT SUCCESSFUL. THE PATIENT WAS HYPOTENSIVE THROUGHOUT THE PROCEDURE SO AN INTRA-AORTIC BALLOON PUMP (IABP) WAS PLACED. WHEN THE PATIENT ARRIVED TO THE CORONARY CARE UNIT (CCU) THE NURSE STATES THAT HE WAS COMPLAINING OF ABDOMINAL PAIN WITH NAUSEA AND VOMITING. SHE MEDICATED HIM FOR THIS BUT SYMPTOMS CONTINUED. APPROXIMATELY 3 HOURS AFTER THE IABP WAS PLACED HE WAS SENT TO COMMUTED TOMOGRAPHY (CT). THE CT IMAGES SHOWED THAT THE INTRA-AORTIC BALLOON (IAB) WAS IN THE AORTA AND THE OPAQUE TIP WAS LOCATED AT THE LUMBAR VERTEBRAE 3 (L3) LEVEL AND WAS OCCLUDING THE ORIGIN OF THE SUPERIOR MESENTERIC ARTERY (SMA) WITH RESULTANT ISCHEMIC GUT AND DIFFUSE PORTAL AND MESENTERIC VENOUS GAS. THE IAB WAS THEN EMERGENTLY REMOVED BY THE CARDIOLOGIST. APPROXIMATE TIME THE IAB WAS IN THE PATIENT WAS 3.5 HOURS. CUSTOMER ADVISE THAT THE CASE IS BEING REVIEWED AS A POTENTIAL DEVICE RELATED DEATH, AND HAVE NOTED THAT THERE ARE OBVIOUSLY MANY QUESTIONS ABOUT PLACEMENT OF THE DEVICE, AND THAT IS A STRUGGLE BECAUSE THERE ARE NO POST PLACEMENT CINE SHOTS FOR VALIDATION AND VISUALIZATION PLACEMENT., AND THAT THE MEDICAL DOCTOR (MD) DID LOOK, BUT DID NOT SEE THE IMAGE. THERE WAS A POST PROCEDURE CHEST X-RAY REVEALED THAT THE PROXIMAL TIP OF THE IAB WAS ¿SEEN ON THE INFERIOR ASPECT OF THE AORTIC ARCH¿. THIS WAS TAKEN 1.5 HOURS PRIOR TO THE CT. ALL REPORTS FROM SURGEON AND INTENSIVIST ARE STATING THAT THE ISCHEMIC BOWL WAS A RESULT OF THE IAB. ON ARRIVAL, THE PATIENT APPEARED TO BE IN ACUTE RENAL FAILURE (NO PRIOR KNOWN HISTORY WITH A CREATINE OF 3.0) WITH ELEVATION OF HIS LIVER ENZYMES AND ELEVATED WHITE BLOOD CELL COUNT. THIS CASE WILL GO THROUGH THE CUSTOMER'S PEER REVIEW PROCESS. IN ADDITION, THERE HAS BEEN NO REPORTED MALFUNCTION OF THE UNKNOWN IABP. UPDATED INFORMATION FROM CUSTOMER: PATIENT PRESENTED TO EMERGENCY DEPARTMENT ON (B)(6) 2018 WITH A ST ELEVATION MYOCARDIAL INFARCTION (STEMI). PATIENT WAS BROUGHT EMERGENTLY TO CATH LAB AT 1317. PATIENT ARRIVED WITH BP OF 100 SYSTOLIC, AND DURING THE COURSE OF INTERVENTION , THE BP DROPPED AND PATIENT WAS PLACED ON PRESSORS AND IABP WAS PLACED UNDER FLUOROSCOPY AT AROUND 1457 AT A 1:1 SETTING. POSITION WAS VERIFIED BY PHYSICIAN; HOWEVER, NO IMAGES WERE SAVED. INTRA AORTIC BALLOON (IAB) WAS SUTURED IN PLACE AND SECURED WITH STAT LOCKS. UPON ARRIVAL TO ICU, THE PATIENT BECAME NAUSEOUS AND BEGAN HAVING ABDOMINAL PAIN. PATIENT HAD CT OF ABDOMEN AND PELVIS AT AROUND 1800 WHICH REPORTED BALLOON TIP AT THE LEVEL OF L3. THE CT SHOWED TIP OF BALLOON WAS OCCLUDING SUPERIOR MESENTERIC ARTERY (SMA) WITH ISCHEMIC GUT AND DIFFUSE PORTAL AND MESENTERIC VENOUS GAS. THE CARDIOLOGIST WAS CALLED AND THE IAB WAS REMOVED BY PHYSICIAN AT APPROXIMATELY 1945 ON (B)(6) 2018. CENTRAL LINE WAS PLACED AND PATIENT WAS INITIATED ON CVHD. PATIENT'S CONDITION CONTINUED TO DETERIORATE AND FAMILY MADE PATIENT DNR. THE PATIENT WAS EXTUBATED PER THE FAMILY'S REQUEST AND EXPIRED ON (B)(6) 2018. INDICATIONS FOR IABP THERAPY WAS CARDIOGENIC SHOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202299 | CARDIOSAVE | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE MAHWAH | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Death |