BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODA BALLOON CATHETER

    MDR report key: 8484358 · Received April 4, 2019

    Report

    Report Number
    1820334-2019-00763
    Event Type
    Injury
    Date Received
    April 4, 2019
    Date of Event
    January 28, 2019
    Report Date
    May 7, 2019
    Manufacturer
    COOK INC
    Product Code
    DQY
    UDI-DI
    10827002484020
    PMA / PMN Number
    K032869
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS: ADDITIONAL INFORMATION: CONCOMITANT PRODUCTS: TFFB-22-82-ZT, LOT# 9171116 ZSLE-11-90-ZT, LOT# 7589621 ZSLE-11-74-ZT, LOT# 9172498 ESBE-24-58-ZT, LOT# 7530242. INVESTIGATION/EVALUATION THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. IMAGING WAS PROVIDED FOR REVIEW. A DOCUMENT BASED INVESTIGATION HAS BEEN PERFORMED INCLUDING A REVIEW OF THE PROVIDED IMAGING, DRAWINGS, INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA. IMAGING WAS RECEIVED AND REVIEWED. PER THE IMAGING REVIEW, AORTIC RUPTURE CANNOT BE CONFIRMED BECAUSE IMAGING OF THE RUPTURE WAS NOT PROVIDED AND ITS SITE WAS NOT SPECIFIED. COOK COULD NOT COMPLETE A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. THE INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: INDICATIONS FOR USE: ¿ THE CODA AND CODA LP BALLOON CATHETERS ARE INTENDED FOR TEMPORARY OCCLUSION OF LARGE VESSELS, OR TO EXPAND VASCULAR PROSTHESES. (MEASURED OUTER WALL TO OUTER WALL). POTENTIAL ADVERSE EVENTS: ¿ VESSEL DISSECTION, PERFORATION, RUPTURE OR INJURY. WARNINGS: ¿ DO NOT EXCEED MAXIMUM INFLATION VOLUME. ADHERE TO BALLOON INFLATION PARAMETERS AS SHOWN IN FIG. 1. OVER-INFLATION OF BALLOON MAY RESULT IN: O DAMAGE TO VESSEL WALL AND/OR VESSEL RUPTURE. O RUPTURE OF BALLOON. ¿ WHEN USED TO EXPAND A VASCULAR PROSTHESIS, THE BALLOON RADIOPAQUE MARKERS SHOULD REMAIN WITHIN THE PROSTHESIS. PRECAUTIONS: ¿ ALWAYS MANIPULATE CATHETER USING FLUOROSCOPIC CONTROL. ¿ ALWAYS MONITOR BALLOON INFLATION USING FLUOROSCOPIC CONTROL. THIS COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. IMAGING NOTED. ¿CONCENTRIC HEAVILY CALCIFIED PLAQUE NARROWED THE DISTAL AORTIC LUMEN TO 13MM OVER A LENGTH OF 12MM. THIS STENOSIS WOULD HAVE REQUIRED OVER DILATION TO ACCOMMODATE EACH ILIAC LEG.¿ IMAGING OF THE ACTUAL PROCEDURE WAS NOT PROVIDED. THE CODA AND CODA LP BALLOON CATHETERS INSTRUCTIONS FOR USE (IFU) (T_CODALP_REV1) STATES, ¿ALWAYS MANIPULATE CATHETER USING FLUOROSCOPIC CONTROL¿ AND ¿ALWAYS MONITOR BALLOON INFLATION USING FLUOROSCOPIC CONTROL.¿ THE TFFB-22-82-ZT INSTRUCTIONS FOR USE (IFU) STATE, ¿USE CARE IN INFLATING THE BALLOON WITHIN THE GRAFT IN THE PRESENCE OF CALCIFICATION, AS EXCESSIVE INFLATION MAY CAUSE DAMAGE TO THE VESSEL.¿ THE CODA AND CODA LP BALLOON CATHETERS IFU (T_CODALP_REV1) ALSO STATES, ¿DO NOT EXCEED MAXIMUM INFLATION VOLUME. ADHERE TO BALLOON INFLATION PARAMETERS AS SHOWN IN FIG. 1. OVER-INFLATION OF BALLOON MAY RESULT IN DAMAGE TO VESSEL WALL AND/OR VESSEL RUPTURE.¿ THIS COMPLAINT FOCUSED ON OVER-INFLATION OF A CODA BALLOON THAT RESULTED IN AORTA TEAR. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE FINDINGS OF THE IMAGING REVIEW: 1. AORTIC RUPTURE CANNOT BE CONFIRMED BECAUSE IMAGING OF THE RUPTURE WAS NOT PROVIDED AND ITS SITE WAS NOT SPECIFIED. RUPTURE WAS REQUIRED AT THE DISTAL AORTA TO ACCOMMODATE THE ILIAC LEGS AND WAS AT INCREASED RISK AT THE PROXIMAL SEALING STENT. 2. DISTAL AORTIC STENOSIS RUPTURE USUALLY IS INCONSEQUENTIAL. HOWEVER, IN THIS CASE, PATENT LUMBAR AND INFERIOR MESENTERIC ARTERIES COULD HAVE SUPPLIED THE RUPTURE. ADDITIONALLY, TYPE IA ENDOLEAK THROUGH SEALING STENT PLEATING MAY HAVE SUPPLIED THE RUPTURE. 3. ATTEMPTS TO ELIMINATE SEALING STENT PLEATING THROUGH AGGRESSIVE MOLDING BALLOON ANGIOPLASTY MAY HAVE RUPTURED THE AORTA IN OR PROXIMAL TO THE SEALING ZONE. 4. SUCCESSFUL RUPTURE CONTROL WITH THE ESBE INDICATES THAT ROOM WAS AVAILABLE TO EXTEND THE SEAL ZONE PROXIMALLY. THIS IS CONSISTENT WITH NECK'S LENGTH AND ANGULATION THAT FAVORED MAINBODY IMPLANTATION 4-5MM BELOW RATHER THAN AT THE RIGHT RENAL ARTERY INFERIOR MARGIN. VESSEL DISSECTION IS A KNOWN INHERENT RISK OF THIS DEVICE. THERE IS NO EVIDENCE THAT THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATIONS. IT SHOULD BE NOTED, THERE IS NO EVIDENCE TO SUGGEST ANY CAUSAL RELATIONSHIP BETWEEN THE TFFB-22-82-ZT AND THE PATIENT¿S TEAR IN THE AORTA. THE AORTA WAS REPAIRED DURING THE INITIAL PROCEDURE. THERE IS NO EVIDENCE TO SUGGEST A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN THE TFFB-22-82-ZT AND THE PATIENT¿S BLEEDING GROIN. THERE IS NO EVIDENCE TO SUGGEST A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN THE TFFB-22-82-ZT AND THE PATIENT¿S DEATH. THEREFORE, NO COMPLAINT WILL BE OPENED FOR THE TFFB-22-82-ZT. THERE IS NO EVIDENCE TO SUGGEST A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN THE CODA BALLOON AND THE PATIENT¿S BLEEDING GROIN. THIS WAS ATTRIBUTED TO A NON-COOK MANUFACTURED CLOSURE DEVICE. THERE IS NO EVIDENCE TO SUGGEST A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN THE CODA BALLOON AND THE PATIENT¿S DEATH. IN ADDITION, THERE IS NO EVIDENCE TO SUGGEST THE FIRST EVENT (AORTA TEAR) AND SECOND EVENT (GROIN BLEEDING) ARE RELATED. OVER-INFLATION OF THE CODA BALLOON CAUSED THE AORTIC RUPTURE BASED ON CUSTOMER TESTIMONY. COOK HAS CONCLUDED PATIENT ANATOMY AND FAILURE TO FOLLOW THE IFU CONTRIBUTED TO THIS INCIDENT. IT IS NOT KNOWN IF THE OVER-INFLATION WAS DONE INTENTIONALLY OR AS A RESULT OF PATIENT ANATOMY. IT WAS A SECONDARY PROCEDURE TO REPAIR GROIN BLEED FROM A NON-COOK MANUFACTURED CLOSURE DEVICE THAT CAUSED / RESULTED IN SUBSEQUENT PROCEDURES AND RESULTED IN THE PATIENT¿S DEATH. A QUALITY ENGINEER RISK ASSESSMENT WAS CONDUCTED TO ASSESS THE RISK OF THIS FAILURE MODE AND CONCLUDED A CHANGE IS NOT REQUIRED, THUS NO RISK REDUCTION ACTIVITIES ARE REQUIRED AT THIS TIME. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    THE ESBE WAS USED DURING THE INITIAL PROCEDURE TO REPAIR AN AORTIC TEAR. A 32MM (9F) CODA WAS USED. THE BALLOON WAS INFLATED WITHIN THE PROXIMAL SEALING STENTS OF THE GRAFT. THE 2ND PROCEDURE TO REPAIR A HEMATOMA IN THE GROIN, WHICH WAS UNRELATED TO COOK PRODUCTS, WAS A DAY OR TWO AFTER THE INITIAL PROCEDURE. IT WAS DURING THIS PROCEDURE THAT THE PATIENT EXPERIENCED SEVERAL CARDIAC ARRESTS. THE PHYSICIAN BELIEVES THESE ARRESTS LED TO ORGAN ISCHEMIA, WHICH LEAD TO MORE SURGERIES TO REMOVE DEAD TISSUES, WHICH EVENTUALLY LEAD TO HER DEATH. NOT SURE OF THE EXACT DAY OF DEATH, BUT IT WAS A COUPLE WEEKS AFTER THE INITIAL PROCEDURE. THE GRAFTS ARE NOT AVAILABLE TO RETURN. IMAGING AND PLANNING/SIZING SHEETS HAVE BEEN PROVIDED FOR REVIEW.

    Additional Manufacturer Narrative · 1

    THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2019 AN INTERNAL DEVICE TRACKING REPORT WAS RECEIVED WHICH CONTAINED INFORMATION THAT A PATIENT DEATH HAD OCCURRED. A LIST OF DEVICES IMPLANTED ON (B)(6) 2019, WAS PROVIDED IN THE REPORT. DEVICES LISTED ON THE REPORT: TFFB-22-82-ZT, LOT# 9171116; ZSLE-11-90-ZT, LOT# 7589621; ZSLE-11-74-ZT, LOT# 9172498; ESBE-24-58-ZT, LOT# 7530242. IN RESPONSE TO A FOLLOW UP. REQUEST FOR ADDITIONAL INFORMATION, THE PHYSICIAN STATED THAT HER DEATH WAS NOT DIRECTLY RELATED TO THE DEVICE. DURING THE INITIAL SURGERY, THEY DID OVER-BALLOON THE DEVICE, WHICH CAUSED A SMALL TEAR IN THE AORTA, BUT WERE ABLE REPAIR THAT IMMEDIATELY. THE PATIENT WAS BROUGHT BACK FOR A SECONDARY SURGERY TO REPAIR BLEEDING IN THE GROIN, WHICH RESULTED FROM THE CLOSURE DEVICE USED, AND NOT RELATED TO THE COOK ENDOGRAFTS. DURING THIS SURGERY, THE PATIENT SUFFERED MULTIPLE CARDIAC EVENTS, WHICH THE DOCTOR BELIEVES WAS THE CAUSE OF THE ISCHEMIC BOWEL EVENT THAT LEAD TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276330 CODA BALLOON CATHETER DQY CATHETER, PERCUTANEOUS DQY COOK INC N/A UNKNOWN 10827002484020

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| R SEE H10