ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
Report
- Report Number
- 1820334-2019-02929
- Event Type
- Malfunction
- Date Received
- November 20, 2019
- Date of Event
- August 7, 2019
- Report Date
- March 12, 2020
- Manufacturer
- COOK INC
- Product Code
- LIT
- UDI-DI
- 10827002503387
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. ADDITIONAL METHOD CODE: COMMUNICATION/INTERVIEWS (4111). SUMMARY OF EVENT: AS REPORTED, DURING AN ENDOVASCULAR THERAPY PROCEDURE, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED. ACCESS WAS GAINED IN THE FEMORAL ARTERY AND A CONTRALATERAL APPROACH WAS USED TO TREAT A CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE COMPLAINT DEVICE WAS ADVANCED TO THE LESION AND THE USER BEGAN TO INFLATE THE BALLOON, WHICH RUPTURED AT 12 ATMOSPHERES. IT IS UNKNOWN IF THE BALLOON RUPTURED CIRCUMFERENTIALLY OR LONGITUDINALLY. THE DEVICE WAS INFLATED OUTSIDE OF A STENT. ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED 04DEC2019. AS REPORTED, THE PATIENT PRESENTED WITH CIRCUMFERENTIAL CALCIFICATIONS TO THE SUPERFICIAL FEMORAL ARTERY. THE DEVICE WAS INFLATED WITH AN UNKNOWN INFLATION DEVICE. FOLLOWING THE RUPTURE OF THE DEVICE, IT WAS REMOVED BY ITSELF FROM THE PATIENT. NO BLOOD WAS NOTED IN THE INFLATION DEVICE. INVESTIGATION EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, SPECIFICATIONS, AND INSPECTION OF UNUSED PRODUCT WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION, NOR WERE IMAGES OF THE DEVICE PROVIDED; HOWEVER, A UNIT FROM THE SAME COMPLAINT LOT WAS EXAMINED. THE BALLOON WAS INFLATED WITH WATER USING A COOK INFLATION DEVICE TO THE RATED BURST PRESSURE, 16 ATMOSPHERES. THE BALLOON DID NOT RUPTURE, DID NOT LEAK, AND THERE WERE NO OBSERVED BALLOON SURFACE DEFECTS. ADDITIONALLY, THE BALLOON BONDS WERE SMOOTH, THERE WERE NO CRACKS OR SIGNS OF DAMAGE TO THE BONDS. THEREFORE, BASED ON THE EXAMINATION TESTING OF THE REPRESENTATIVE DEVICE, THERE IS EVIDENCE TO SUGGEST THAT THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THREE POTENTIALLY RELATED NON-CONFORMANCES WERE FOUND; HOWEVER, THE AFFECTED UNITS WERE SCRAPPED. THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE COMPLAINT FILE, DEVICE HISTORY RECORD, COMPLAINT HISTORY, VALIDATION, AND QUALITY CONTROL DOCUMENTS PROVIDE EVIDENCE TO SUPPORT THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. THE PRODUCT IFU STATES THE FOLLOWING: ¿THE BALLOON IS MANUFACTURED FROM AN EXTRA-THINWALL, HIGH-STRENGTH, MINIMALLY COMPLIANT MATERIAL. PARTICULAR CARE SHOULD BE TAKEN IN HANDLING THE BALLOON TO PREVENT DAMAGE. IT WILL INFLATE TO THE INDICATED SIZE PARAMETERS WHEN UTILIZING PROPER PRESSURE RECOMMENDATIONS. ADHERE TO BALLOON INFLATION PRESSURE PARAMETERS INDICATED IN THE COMPLIANCE CARD INSERT. REFER TO LABEL FOR FURTHER INFORMATION. USE OF A PRESSURE GAUGE IS RECOMMENDED TO MONITOR INFLATION PRESSURES. DO NOT EXCEED RATED BURST PRESSURE. RUPTURE OF BALLOON MAY OCCUR. OVER-INFLATION MAY CAUSE RUPTURE OF THE BALLOON, WITH RESULTANT DAMAGE TO THE VESSEL WALL. USE OF A PRESSURE GAUGE IS RECOMMENDED TO MONITOR INFLATION PRESSURES. DO NOT USE A POWER INJECTOR FOR BALLOON INFLATION. RUPTURE MAY OCCUR. IN HEAVILY SCARRED ACCESS SITES, USE OF AN INTRODUCER SHEATH IS RECOMMENDED. UPON REMOVAL FROM PACKAGE, INSPECT CATHETER TO ENSURE NO DAMAGE HAS OCCURRED DURING SHIPPING. INFLATE BALLOON TO DESIRED PRESSURE. IF BALLOON PRESSURE IS LOST AND/OR BALLOON RUPTURE OCCURS, DEFLATE BALLOON AND REMOVE BALLOON AND SHEATH AS A UNIT. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT.¿ BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A DEFINITIVE CAUSE CANNOT BE DETERMINED; ALTHOUGH, IT IS POSSIBLE THAT THE PATIENT¿S ANATOMY COULD HAVE CONTRIBUTED TO THIS INCIDENT AS IT WAS REPORTED THAT THERE WERE CIRCUMFERENTIAL VESSEL CALCIFICATIONS. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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) 2019. AS REPORTED, THE PATIENT PRESENTED WITH CIRCUMFERENTIAL CALCIFICATIONS TO THE SUPERFICIAL FEMORAL ARTERY. THE DEVICE WAS INFLATED WITH AN UNKNOWN INFLATION DEVICE. FOLLOWING THE RUPTURE OF THE DEVICE, IT WAS REMOVED BY ITSELF FROM THE PATIENT. NO BLOOD WAS NOTED IN THE INFLATION DEVICE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
PMA/510(K) NUMBER = K170193. 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 ENDOVASCULAR THERAPY PROCEDURE, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED. ACCESS WAS GAINED IN THE FEMORAL ARTERY AND A CONTRALATERAL APPROACH WAS USED TO TREAT A CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE COMPLAINT DEVICE WAS ADVANCED TO THE LESION AND THE USER BEGAN TO INFLATE THE BALLOON, WHICH RUPTURED AT 12 ATMOSPHERES. IT IS UNKNOWN IF THE BALLOON RUPTURED CIRCUMFERENTIALLY OR LONGITUDINALLY. THE DEVICE WAS INFLATED OUTSIDE OF A STENT. ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1144531 | ADVANCE 14 LP LOW PROFILE BALLOON CATHETER | LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | COOK INC | G50338 | 9393784 | 10827002503387 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |