MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,07,08 report with the FDA on 2009-08-05 for TANDEM XL ERCP CANNULA M00535700 3570 manufactured by Boston Scientific Corporation.
[1234299]
It was initially reported to boston scientific corporation in 2009, that a tandem xl ercp cannula and a hydra jagwire guidewire were used during an endoscopic retrograde cholangiopancreatography procedure performed the day before. According to the complainant, during the procedure, the physician was unable to advance the guidewire through this device. The procedure was completed successfully with another tandem xl ercp cannula 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. This event has been deemed a reportable event based on the investigation results: smashed tip.
Patient Sequence No: 1, Text Type: D, B5
[8369027]
Visual examination of the returned device revealed the working length had multiple bends in it, and 0. 5 centimeters of the device distal tip was found to be partially collapsed. A 0. 035 inch guidewire could not pass through the damaged area, as it appeared that during insertion of the device into the scope, or during use of the device, the distal tip was smashed, which did not allow the guidewire to pass. The most probable root cause is operational context.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2009-03699 |
| MDR Report Key | 1490376 |
| Report Source | 00,01,07,08 |
| Date Received | 2009-08-05 |
| Date of Report | 2009-07-10 |
| Date Mfgr Received | 2009-07-10 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2009-11-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLES MONTGOMERY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836132 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TANDEM XL ERCP CANNULA |
| Product Code | ODD |
| Date Received | 2009-08-05 |
| Returned To Mfg | 2009-06-18 |
| Model Number | M00535700 |
| Catalog Number | 3570 |
| Lot Number | 12463444 |
| ID Number | NA |
| Device Expiration Date | 2011-03-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | SPENCER IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-05 |