ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
Report
- Report Number
- 1820334-2020-00046
- Event Type
- Malfunction
- Date Received
- January 3, 2020
- Date of Event
- December 17, 2019
- Report Date
- April 16, 2020
- Manufacturer
- COOK INC
- Product Code
- LIT
- UDI-DI
- 10827002503318
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
INITIAL REPORT: AS REPORTED, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY INVOLVING A PATIENT WITH A HISTORY OF PERIPHERAL ARTERY DISEASE, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED. ACCESS WAS OBTAINED IN THE LEFT FEMORAL ARTERY AND A CONTRALATERAL APPROACH WAS USED TO TREAT A STENOSED LESION WITHIN THE RIGHT SUPERFICIAL FEMORAL ARTERY. ANOTHER MANUFACTURER'S 0.014 INCH WIRE GUIDE PASSED THROUGH THE LESION, AND THE COMPLAINT DEVICE WAS THEN INFLATED; HOWEVER, THE DEVICE RUPTURED AT 16 ATMOSPHERES. THE BALLOON WAS REMOVED AND EXCHANGED FOR ANOTHER MANUFACTURER'S BALLOON TO COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION ¿ EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, QUALITY CONTROL PROCEDURES, AND SPECIFICATIONS OF THE DEVICE AS WELL AS A VISUAL INSPECTION AND FUNCTIONAL TEST OF AN UNUSED DEVICE DURING WERE CONDUCTED THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; HOWEVER, A UNIT FROM THE COMPLAINT LOT WAS IN COOK CONTROL AND WAS USED AS A REPRESENTATIVE DEVICE FOR THIS INVESTIGATION. DURING EXAMINATION OF THE REPRESENTATIVE UNIT, THE BALLOON WAS INFLATED WITH WATER USING A COOK INFLATION DEVICE TO THE RATED BURST PRESSURE, 16ATM. ONCE INFLATED TO 16ATM, THE BALLOON DID NOT RUPTURE AND SHOWED NO LEAKS. THERE WERE NO SURFACE DEFECTS NOTED TO THE BALLOON AND NO DAMAGE NOTED TO THE DEVICE. THE BALLOON BONDS WERE SMOOTH. ADDITIONALLY, DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THE EVIDENCE INDICATES THE PRODUCT WAS MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. AS THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWINGS, SPECIFICATIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. AN IFU IS PROVIDED WITH THIS DEVICE, WHICH WARNS ¿DO NOT EXCEED RATED BURST PRESSURE. 1 RUPTURE OF BALLOON MAY OCCUR. ADHERE TO BALLOON INFLATION PRESSURE PARAMETERS IN THE COMPLIANCE CARD INSERT. 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.¿ THE IFU GOES ON TO NOTE ¿IF RESISTANCE IS ENCOUNTERED WHILE ADVANCING THE BALLOON DILATATION CATHETER, DETERMINE THE CAUSE AND PROCEED WITH CAUTION¿INFLATE BALLOON TO DESIRED PRESSURE. ADHERE TO RECOMMENDED BALLOON INFLATION PRESSURES.¿ AND FINALLY, ¿IF BALLOON PRESSURE IS LOST AND/OR BALLOON RUPTURE OCCURS, DEFLATE BALLOON AND REMOVE BALLOON AND SHEATH AS A UNIT.¿ BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, COOK HAS CONCLUDED THAT PATIENT ANATOMY CONTRIBUTED TO THIS INCIDENT. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS SEVERELY CALCIFIED. 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.
ADDITIONAL INFORMATION: SEE B5. 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 WAS RECEIVED 07JAN2020. AS REPORTED, THE PATIENT PRESENTED WITH SEVERE VESSEL CALCIFICATION BUT NO TORTUOSITY. THE DEVICE RUPTURE OCCURRED DURING THE FIRST INFLATION WITH AN "INDEFLATOR".
CONCOMITANT PRODUCTS= WIRE: GLADIUS MG14 PV ES, RPN#: PP14R304P, LOT#: 190826A281, PRODUCED BY ASAHI INTECC. 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 A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY INVOLVING A PATIENT WITH A HISTORY OF PERIPHERAL ARTERY DISEASE, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED. ACCESS WAS OBTAINED IN THE LEFT FEMORAL ARTERY AND A CONTRALATERAL APPROACH WAS USED TO TREAT A STENOSED LESION WITHIN THE RIGHT SUPERFICIAL FEMORAL ARTERY. ANOTHER MANUFACTURER'S 0.014 INCH WIRE GUIDE PASSED THROUGH THE LESION, AND THE COMPLAINT DEVICE WAS THEN INFLATED; HOWEVER, THE DEVICE RUPTURED AT 16 ATMOSPHERES. THE BALLOON WAS REMOVED AND EXCHANGED FOR ANOTHER MANUFACTURER'S BALLOON TO COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9572 | ADVANCE 14 LP LOW PROFILE BALLOON CATHETER | LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | COOK INC | G50331 | 8652251 | 10827002503318 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | SEE H10 |