CXI SUPPORT CATHETER
Report
- Report Number
- 1820334-2021-01185
- Event Type
- Malfunction
- Date Received
- April 21, 2021
- Date of Event
- April 6, 2021
- Report Date
- July 19, 2021
- Manufacturer
- COOK INC
- Product Code
- KRA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. ADDITIONAL INFORMATION: B5, D10. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.
EVENT SUMMARY: AS REPORTED, DURING AN ANGIOPLASTY PROCEDURE, THE TIP OF AN UNSPECIFIED CXI SUPPORT CATHETER SEPARATED. ACCESS WAS OBTAINED USING AN UNKNOWN 5 FRENCH SHEATH IN THE COMMON FEMORAL ARTERY TO TARGET THE DISTAL ANTERIOR TIBIAL ARTERY. ANOTHER MANUFACTURER'S WIRE GUIDE WAS PASSED THROUGH THE CALCIFIED, OCCLUDED LESION. AS THE USER ATTEMPTED TO PASS THE COMPLAINT DEVICE OVER THE WIRE, THE TIP BECAME STUCK IN CALCIUM AND SEPARATED, AFTER RESISTANCE WAS ENCOUNTERED. THE TIP OF THE CATHETER WAS REMOVED WITHOUT ISSUE THROUGH A 5 FRENCH DEVICE. INVESTIGATION - EVALUATION: A DOCUMENT-BASED INVESTIGATION WAS PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, MANUFACTURING INSTRUCTIONS, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL DATA. THE CUSTOMER DID NOT RETURN THE COMPLAINT DEVICE FOR EVALUATION. HOWEVER, PICTURES WERE PROVIDED. THE PICTURES IN THE EMAIL SHOW THAT THE TIP IS MUTILATED AND THE COATING SEPARATED FROM THE SHAFT OF THE CATHETER. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER FOR THE COMPLAINT DEVICES. COOK REVIEWED THE SALES HISTORY FOR THIS CUSTOMER AND WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THERE IS NO EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: "INTENDED USE: THE CXI SUPPORT CATHETER IS INTENDED FOR USE IN SMALL VESSEL OR SUPERSELECTIVE ANATOMY FOR DIAGNOSTIC AND INTERVENTIONAL PROCEDURES, INCLUDING PERIPHERAL USE. PRECAUTIONS: THE CATHETER SHOULD NOT BE ADVANCED INTO A VESSEL HAVING A REFERENCE VESSEL DIAMETER SMALLER THAN THE CATHETER OUT DIAMETER. THE CATHETER SHOULD NOT BE ADVANCED THROUGH AN AREA OF RESISTANCE UNLESS THE SOURCE OF RESISTANCE IS IDENTIFIED BY FLUOROSCOPY AND APPROPRIATE STEPS ARE TAKEN TO REDUCE OR REMOVE THE OBSTRUCTION. HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿. THE PICTURES SHOW THE MUTILATED TIP AND PROCEDURE INFORMATION NOTES A CALCIFIED, OCCLUDED LESION, THAT THE DEVICE GOT STUCK IN AND SEPARATED AFTER RESISTANCE OCCURRED. CURRENT INFORMATION SUPPORTS THE CONCLUSION THAT PATIENT ANATOMY CONTRIBUTED TO THIS INCIDENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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.
ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2021. THE PROCEDURE INVOLVED A CRURAL ANGIOPLASTY. ACCESS WAS OBTAINED USING AN UNKNOWN 5 FRENCH SHEATH IN THE COMMON FEMORAL ARTERY TO TARGET THE DISTAL ANTERIOR TIBIAL ARTERY. ANOTHER MANUFACTURER'S WIRE GUIDE WAS PASSED THROUGH THE CALCIFIED, OCCLUDED LESION. AS THE USER ATTEMPTED TO PASS THE COMPLAINT DEVICE OVER THE WIRE, THE TIP SEPARATED AFTER RESISTANCE WAS ENCOUNTERED. THE SEPARATED PORTION WAS PULLED INTO A 5 FRENCH DEVICE AND REMOVED SUCCESSFULLY.
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
(B)(6). PMA/510K # K122796 OR K160884. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
AS REPORTED, DURING AN UNKNOWN PROCEDURE THE TIP OF AN UNSPECIFIED CXI SUPPORT CATHETER BROKE OFF. THE TIP OF THE CATHETER BECAME STUCK IN CALCIUM WITHIN THE CRURAL VESSELS AND BROKE OFF. THE TIP OF THE CATHETER WAS REMOVED WITHOUT ISSUE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PORTION OF THE DEVICE WAS LEFT WITHIN THE PATIENT. THIS DID NOT RESULT IN PROLONGED HOSPITALIZATION OR ADDITIONAL PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 602008 | CXI SUPPORT CATHETER | KRA CATHETER, CONTINUOUS FLUSH | KRA | COOK INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | V18 WIRE, 5 FR MPA |