PT 2 (TM)
Report
- Report Number
- 2134265-2011-02620
- Event Type
- Injury
- Date Received
- July 14, 2011
- Date of Event
- March 9, 2011
- Report Date
- June 14, 2011
- Manufacturer
- BOSTON SCIENTIFIC - COSTA RICA
- Product Code
- DQX
- PMA / PMN Number
- K030617
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- RISK MANAGER
Narratives
DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).
EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED THE WIRE WAS NOT FRACTURED; HOWEVER, 1CM OF POLY WAS MISSING FROM THE TIP, EXPOSING THE CORE WIRE WHICH WAS NOTED TO BE FLAT. THE LENGTH OF THE DEVICE WAS 185CM. ALL OUTER DIAMETER MEASUREMENTS TAKEN WERE WITHIN SPECIFICATIONS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).
(B)(4). IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A GUIDE WIRE TIP DETACHMENT AND DISSECTION OCCURRED. AT AN UNSPECIFIED TIME DURING THE PROCEDURE, A LINEAR DISSECTION WAS IDENTIFIED IN THE DIAGONAL BRANCH DURING REPEAT ANGIOGRAPHY. A 3.0X15MM BALLOON WAS PLACED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND A 2.5X15MM NON BSC STENT WAS PLACED IN THE DIAGONAL AND DEPLOYED AT 10ATMS WITH SIMULTANEOUS INFLATION OF THE BALLOON IN THE LAD. KISSING BALLOON ANGIOPLASTY WAS PERFORMED USING A 2.5MM BALLOON IN THE DIAGONAL AND A 3.0X15MM BALLOON IN THE LAD TO 8ATMS. ANGIOGRAPHY AT THIS POINT REVEALED GOOD STENT EXPANSION IN THE LAD AND THE DIAGONAL. AN UNSPECIFIED GUIDE WIRE WAS REMOVED FROM THE LAD. THE PT2 MODERATE SUPPORT GUIDE WIRE HAD BEEN PLACED IN THE DIAGONAL AND WHILE ATTEMPTING TO REMOVE IT, THE DISTAL TIP BECAME ENTANGLED WITH THE DISTAL END OF THE 2.5X15 NON BSC STENT. A 2.0X15MM BALLOON, A 1.5X1.5MM BALLOON AND A GUIDELINER WERE EACH UTILIZED IN UNSUCCESSFUL ATTEMPTS TO DISLODGE THE TIP FROM THE STENT. WITH A 1.5MM BALLOON ADVANCED TO THE DISTAL TIP OF THE GUIDE WIRE, THE PHYSICIAN PULLED BACK WHICH RESULTED IN THE TIP OF THE WIRE DETACHING. TREATMENT WAS CONTINUED IN THE LAD WITH DILATION AND IMPLANTATION OF A NON BSC BARE METAL STENT. AN ATTEMPT TO RE-WIRE THE DIAGONAL WITH A NON BSC WIRE WAS UNSUCCESSFUL. ANOTHER PT2 MODERATE SUPPORT GUIDE WIRE WAS THEN ADVANCED TO THE DIAGONAL AND DILATION WAS PERFORMED WITH A 1.5X15MM BALLOON TO 16ATMS AND A 2.5X15MM BALLOON TO 12ATMS. ANGIOGRAPHY AT THIS POINT REVEALED GOOD FLOW IN THE DIAGONAL AND A SHORT SEGMENT OF THE PROXIMAL LAD WHICH APPEARED TO BE UNCOVERED. THEREFORE, A NON BSC BARE METAL STENT WAS IMPLANTED. ANGIOGRAPHY THEN REVEALED WIDELY PATENT STENTS AND GOOD FLOW IN THE LAD. THE STENTS IN THE DIAGONAL WERE FULLY DEPLOYED. THE PT2 WIRE FRAGMENT REMAINED IN THE DISTAL END OF THE STENT AND APPEARED TO BE IMMOBILE. WITH GOOD FLOW INTO BOTH VESSELS AND CONSIDERING THE AMOUNT OF DYE USED, THE PROCEDURE WAS COMPLETED. TWO DAYS POST PROCEDURE, THE PATIENT UNDERWENT INTRAVENOUS ULTRASOUND (IVUS) WHICH REVEALED PATENT STENTS IN THE LAD AND A DISSECTION DISTAL TO THE STENT PLACED IN THE DIAGONAL. A 2.25X28MM NON BSC STENT WAS IMPLANTED TO COVER THE DISSECTION WITHOUT FURTHER ISSUE. IT WAS NOTED THAT THE "DISTAL WIRE TIP RESULTED IN THE DISSECTION IN THE DIAGONAL." THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS DISCHARGED TO HIS HOME.
(B)(4). IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A GUIDE WIRE TIP DETACHMENT AND DISSECTION OCCURRED. AT AN UNSPECIFIED TIME DURING THE PROCEDURE, A LINEAR DISSECTION WAS IDENTIFIED IN THE DIAGONAL BRANCH DURING REPEAT ANGIOGRAPHY. A 3.0X15MM BALLOON WAS PLACED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND A 2.5X15MM NON BSC STENT WAS PLACED IN THE DIAGONAL AND DEPLOYED AT 10ATMS WITH SIMULTANEOUS INFLATION OF THE BALLOON IN THE LAD. KISSING BALLOON ANGIOPLASTY WAS PERFORMED USING A 2.5MM BALLOON IN THE DIAGONAL AND A 3.0X15MM BALLOON IN THE LAD TO 8ATMS. ANGIOGRAPHY AT THIS POINT REVEALED GOOD STENT EXPANSION IN THE LAD AND THE DIAGONAL. AN UNSPECIFIED GUIDE WIRE WAS REMOVED FROM THE LAD. THE PT2 MODERATE SUPPORT GUIDE WIRE HAD BEEN PLACED IN THE DIAGONAL AND WHILE ATTEMPTING TO REMOVE IT, THE DISTAL TIP BECAME ENTANGLED WITH THE DISTAL END OF THE 2.5X15 NON BSC STENT. A 2.0X15MM BALLOON, A 1.5X1.5MM BALLOON AND A GUIDELINER WERE EACH UTILIZED IN UNSUCCESSFUL ATTEMPTS TO DISLODGE THE TIP FROM THE STENT. WITH A 1.5MM BALLOON ADVANCED TO THE DISTAL TIP OF THE GUIDE WIRE, THE PHYSICIAN PULLED BACK WHICH RESULTED IN THE TIP OF THE WIRE DETACHING. TREATMENT WAS CONTINUED IN THE LAD WITH DILATION AND IMPLANTATION OF A NON BSC BARE METAL STENT. AN ATTEMPT TO RE-WIRE THE DIAGONAL WITH A NON BSC WIRE WAS UNSUCCESSFUL. ANOTHER PT2 MODERATE SUPPORT GUIDE WIRE WAS THEN ADVANCED TO THE DIAGONAL AND DILATION WAS PERFORMED WITH A 1.5X15MM BALLOON TO 16ATMS AND A 2.5X15MM BALLOON TO 12ATMS. ANGIOGRAPHY AT THIS POINT REVEALED GOOD FLOW IN THE DIAGONAL AND A SHORT SEGMENT OF THE PROXIMAL LAD WHICH APPEARED TO BE UNCOVERED. THEREFORE, A NON BSC BARE METAL STENT WAS IMPLANTED. ANGIOGRAPHY THEN REVEALED WIDELY PATENT STENTS AND GOOD FLOW IN THE LAD. THE STENTS IN THE DIAGONAL WERE FULLY DEPLOYED. THE PT2 WIRE FRAGMENT REMAINED IN THE DISTAL END OF THE STENT AND APPEARED TO BE IMMOBILE. WITH GOOD FLOW INTO BOTH VESSELS AND CONSIDERING THE AMOUNT OF DYE USED, THE PROCEDURE WAS COMPLETED. TWO DAYS POST PROCEDURE, THE PATIENT UNDERWENT INTRAVENOUS ULTRASOUND (IVUS) WHICH REVEALED PATENT STENTS IN THE LAD AND A DISSECTION DISTAL TO THE STENT PLACED IN THE DIAGONAL. A 2.25X28MM NON BSC STENT WAS IMPLANTED TO COVER THE DISSECTION WITHOUT FURTHER ISSUE. IT WAS NOTED THAT THE "DISTAL WIRE TIP RESULTED IN THE DISSECTION IN THE DIAGONAL." THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS DISCHARGED TO HIS HOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PT 2 (TM) | WIRE, GUIDE, CATHETER | DQX | BOSTON SCIENTIFIC - COSTA RICA | H74938931030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Other| R | 2.5X15MM ABBOTT MINI VISION STENT| 2.5MM BALLOON CATHETER |