ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER
Report
- Report Number
- 1820334-2018-02820
- Event Type
- Injury
- Date Received
- September 27, 2018
- Date of Event
- September 11, 2018
- Report Date
- January 11, 2019
- Manufacturer
- COOK INC
- Product Code
- LIT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- PHYSICIAN
Narratives
G5: PMA/510(K) NUMBER = K130293. 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, UNAVAILABLE, OR UNCHANGED. INVESTIGATION ¿ EVALUATION A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE BALLOON HAD RUPTURED CIRCUMFERENTIALLY. BIOMATTER WAS PRESENT ALONG THE LENGTH OF THE DEVICE. THE DISTAL PORTION OF THE BALLOON CATHETER HAD SEPARATED. NO NONCONFORMANCES WERE OBSERVED. DURING THE INVESTIGATION IT WAS NOTED THAT THE PROXIMAL MARKER BAND WAS PRESENT, HOWEVER THE SECOND MARKER BAND WAS ABSENT. INVESTIGATION CONFIRMED WITH THE FACILITY THAT NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. ADDITIONALLY, 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 SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD ALSO BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. MOREOVER, AN IFU IS PROVIDED WITH THE DEVICE, WHICH STATES A WARNING AGAINST EXCEEDING THE RATED BURST PRESSURE, WHICH MAY RESULT IN RUPTURE. THE INSTRUCTIONS ALSO LIST TO INFLATE THE BALLOON TO THE DESIRED PRESSURE AND TO ADHERE TO THE RECOMMENDED BALLOON INFLATION PRESSURES. THE IFU MAKES IT KNOWN THAT PARTICULAR CARE SHOULD BE TAKEN IN HANDLING THE BALLOON TO PREVENT DAMAGE. UPON OPENING AND REMOVING THE DEVICE, INSPECTION OF THE CATHETER IS REQUIRED TO ENSURE NO DAMAGE HAS OCCURRED DURING SHIPPING. FURTHERMORE, A REVIEW OF THE QUALITY CONTROL PROCEDURES WAS CONDUCTED, AND NO GAPS WERE DISCOVERED. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE TRACED TO THE DEVICE. AS THE PHYSICIAN NOTED THE DEVICE WAS INFLATED THEN DEFLATED MULTIPLE TIMES, PATIENT CONDITION IS THE MOST LIKELY FACTOR FOR THIS DEVICE FAILURE. 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
COMMON NAME & PRODUCT CODE = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. PMA/510(K) NUMBER = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED, AN ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER RUPTURED CIRCUMFERENTIALLY DURING REMOVAL. ACCORDING TO THE PHYSICIAN, THE COMPLAINT DEVICE HAD BEEN INFLATED MANY TIMES DURING A PERIPHERAL ARTERIAL REVASCULARIZATION PROCEDURE. INFLATION PRESSURE AT THE TIME OF RUPTURE WAS 14 ATMOSPHERES (ATM). IT WAS INFLATED OVER THE STEEP, NON-CALCIFIED BIFURCATION INSIDE AN OLD STENT IN THE RIGHT EXTERNAL ILIAC ARTERY AND THE BALLOON HAD BEEN INFLATED INSIDE. THE PHYSICIAN BELIEVED THIS MIGHT HAVE CAUSED THE BALLOON TO RUPTURE AND TEAR. THE PHYSICIAN STATED HE DID NOT BLAME THE ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER FOR RUPTURING AS THEY "ABUSED" THE BALLOON AND INFLATED IT MANY TIMES. THE RUPTURED BALLOON WAS SUCCESSFULLY REMOVED BY UTILIZING A SNARE WHICH HAD BEEN PLACED THROUGH AN 8FR SHEATH INSIDE A 10FR SHEATH AND EMPLOYING A VACUUMING TECHNIQUE. AFTER REMOVAL, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY ADVERSE EFFECT TO THE PATIENT. PRODUCT AND LOT NUMBERS ARE UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 756349 | ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER | LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | COOK INC | 8426673 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PREVIOUSLY STATED.| PREVIOUSLY STATED. |