MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,07 report with the FDA on 2009-02-03 for TANDEM XL ERCP CANNULA M00535700 3570 manufactured by Boston Scientific Corporation.
[1045992]
Note: this report pertains to the first of two events that occurred during the same procedure. Refer to associated manufacturer report# 3005099803-2009-00343 for a description of the other event. It was reported to boston scientific corporation in 2009 that a tandem xl ercp cannula was used during a procedure. According to the complainant, the guidewire was "caught in the cannula" during the exchange so "the cannula was cut at the proximal". The procedure was completed with another tandem xl ercp cannula. 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".
Patient Sequence No: 1, Text Type: D, B5
[8183690]
Although the suspect device has been received, the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2009-00344 |
| MDR Report Key | 1345178 |
| Report Source | 00,01,05,07 |
| Date Received | 2009-02-03 |
| Date of Report | 2009-01-05 |
| Date of Event | 2009-01-05 |
| Date Mfgr Received | 2009-01-05 |
| Device Manufacturer Date | 2008-10-01 |
| Date Added to Maude | 2009-06-15 |
| 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 | 0 |
| 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 DR. |
| 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 | 2009-02-03 |
| Returned To Mfg | 2009-01-26 |
| Model Number | M00535700 |
| Catalog Number | 3570 |
| Lot Number | 12105853 |
| ID Number | NA |
| Device Expiration Date | 2010-10-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | SPENCER IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-03 |