ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
Report
- Report Number
- 1820334-2019-00048
- Event Type
- Malfunction
- Date Received
- January 2, 2019
- Date of Event
- December 25, 2018
- Report Date
- March 28, 2019
- Manufacturer
- COOK INC
- Product Code
- LIT
- UDI-DI
- 10827002503141
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
INVESTIGATION/EVALUATION: REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURES INSTRUCTIONS, AND QUALITY CONTROL OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. ADDITIONALLY, REVIEWS OF THE MANUFACTURES INSTRUCTIONS, DRAWING, QUALITY CONTROL PROCEDURES, AND OVERALL DESIGN HISTORY RECORD WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. FURTHERMORE, AN IFU IS PROVIDED WITH THIS DEVICE, WHICH STATES THE INTENDED USES AS ¿PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF LESIONS IN PERIPHERAL ARTERIES, INCLUDING ILIAC, RENAL, POPLITEAL, INFRAPOPLITEAL, FEMORAL AND ILIOFEMORAL, AS WELL AS OBSTRUCTIVE LESIONS OF NATIVE OR SYNTHETIC ARTERIOVENOUS DIALYSIS FISTULAE.¿ THERE IS NO INDICATION THAT THE CUSTOMER USED THE DEVICE OUTSIDE OF THE APPROPRIATE PARAMETERS. BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THAT THIS EVENT CANNOT BE TRACED TO THE DEVICE, BUT IS IN FACT, A ONE OFF DUE TO THE PATIENT SEVERELY CALCIFIED CONDITION. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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, UNAVAILABLE, OR UNCHANGED. ADDITIONAL INFORMATION ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019. THE FOLLOWING FIELDS HAVE BEEN B5: THE PROCEDURE INVOLVED IN THIS CASE WAS ENDOVASCULAR THERAPY. PATIENT DEMOGRAPHICS AND PRE-EXISTING CONDITIONS ARE UNKNOWN. ANOTHER MANUFACTURER'S INFLATION DEVICE WAS USED TO INFLATE THE BALLOON TO 8 ATMOSPHERES. IT IS UNKNOWN HOW MANY TIMES THE BALLOON WAS INFLATED OR THE DURATION OF EACH INFLATION. THE TYPE OF CONTRAST AS WELL AS RATIO OF CONTRAST TO SALINE IS UNKNOWN. THE BALLOON WAS SOLELY REMOVED THROUGH THE SHEATH UPON RUPTURE. IT IS UNKNOWN IF THE BALLOON RUPTURED CIRCUMFRENTIALLY OR LONGITUDINALLY. THE BALLOON WAS NOT INFLATED INSIDE OF A STENT PRIOR TO RUPTURE. D11: CONCOMITANT PRODUCTS - 14INCH/ASAHI INTECC WIRE GUIDE, 6FR/TERUMO SHEATH, EVEREST/MEDTRONIC INFLATION DEVICE 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. THIS INFORMATION IS DETAILED IN SECTION H10.
DEVICE AVAILABLE FOR EVALUATION: PER THE INITIAL REPORTER, THE DEVICE WILL NOT BE RETURNED. 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.
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED. THE PATIENT WAS REPORTED TO HAVE A SEVERELY CALCIFIED LESION IN THE POPLITEAL ARTERY. WHEN THE BALLOON WAS ADVANCED THROUGH THE FEMORAL ARTERY TO THE LESION, IT RUPTURED. ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT HAS NOT BEEN REPORTED THAT ANY SECTION OF THE DEVICE REMAINED IN THE PATIENT OR THAT THE PATIENT REQUIRED ADDITIONAL PROCEDURES AS A RESULT OF THE EVENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. IT HAS ALSO BEEN PROVIDED THAT THE COMPLAINT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT ANATOMY HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 332 | ADVANCE 14 LP LOW PROFILE BALLOON CATHETER | LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | COOK INC | G50314 | 7276235 | 10827002503141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |