MICROVASIVE MAXFORCE
Report
- Report Number
- 3005099803-2010-04515
- Event Type
- Malfunction
- Date Received
- October 25, 2010
- Date of Event
- September 29, 2010
- Report Date
- September 29, 2010
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- KNQ
- PMA / PMN Number
- K934697
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4):ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.
VISUAL ANALYSIS OF THE RETURNED COMPLAINT DEVICE REVEALED NO DAMAGE TO THE CATHETER OF THE DEVICE. THE BALLOON PORTION OF THE DEVICE PRESENTED PARTIALLY INFLATED WITH CLEAR LIQUID. MICROSCOPIC EXAMINATION OF THE BALLOON REVEALED NO DAMAGE. THE RETURNED INCIDENT DEVICE WAS FUNCTIONALLY TESTED PER SPECIFICATION. INFLATION WAS ATTEMPTED USING AN ENCORE INFLATION DEVICE, AND A LEAK WAS NOTED IN THE CATHETER NEAR THE POINT WHERE THE FLAG LABEL IS AFFIXED. THE STRAIN RELIEF WAS REMOVED, AND THE HUB WAS DISSECTED IN SECTIONS IN ORDER TO LOCATE THE LEAK; IT WAS CONFIRMED A LEAK WAS LOCATED AT THE END OF THE HUB, UNDER THE STRAIN RELIEF. THE LOCATION OF THE MOULDED SUB COMPONENTS WAS REVIEWED TO ENSURE THAT ALL PARTS WERE IN THE CORRECT LOCATION; IT WAS DETERMINED THAT THE MANUFACTURING SPECIFICATION WAS MET. BASED ON THE CONDITION OF THE RETURNED INCIDENT DEVICE, THE COMPLAINT THAT THE BALLOON WAS TORN WAS NOT CONFIRMED, THEREFORE THIS IS NOW NOT AN MDR REPORTABLE EVENT. HOWEVER, THE LEAK NOTED DURING ANALYSIS COULD HAVE CONTRIBUTED TO INFLATION DIFFICULTIES EXPERIENCED DURING THE PROCEDURE. THE ROOT CAUSE OF THE LEAK FOUND UNDER THE STRAIN RELIEF CANNOT BE DETERMINED, HOWEVER THERE IS AN INVESTIGATION IN PROGRESS TO DETERMINE THE ROOT CAUSE OF THIS TYPE OF LEAK. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE DILATATION BALLOON CATHETER WAS USED DURING AN ESOPHAGEAL DILATATION PROCEDURE PERFORMED ON (B)(6), 2010 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS ADVANCED TO THE STENOSIS, BUT COULD NOT BE INFLATED DUE TO A TEAR. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL; IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE DILATATION BALLOON CATHETER WAS USED DURING AN ESOPHAGEAL DILATATION PROCEDURE PERFORMED ON (B)(6), 2010 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS ADVANCED TO THE STENOSIS, BUT COULD NOT BE INFLATED DUE TO A TEAR. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL; IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROVASIVE MAXFORCE | DILATOR, ESOPHAGEAL | KNQ | BOSTON SCIENTIFIC - GALWAY | M00589150 | 13414688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |