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 2009-02-25 for TANDEM XL ERCP CANNULA M00535700 3570 manufactured by Boston Scientific Corporation.
[17533155]
It was reported to boston scientific corporation in 2009, that a tandem xl ercp cannula was used during an endoscopic retrograde cholangiopancreatography procedure performed eight days prior. According to the complainant , during the procedure, the guidewire got caught and could not be removed from the cannula device. This event occurred inside the pt. The device and the guidewire were removed together from the scope. The procedure was completed with a different device (manufacturer unk). There were no pt complications reported as a result of this event. The pt's condition at the conclusion of the procedure was reported to be "good".
Patient Sequence No: 1, Text Type: D, B5
[17684974]
This complainant was unable to provide the suspect device lot number; therefore, the device manufacturer date and expiration date are unk. The device has been received by this manufacturer, however, the investigation has not yet been performed. Upon 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2009-00754 |
| MDR Report Key | 1355563 |
| Report Source | 00,01,05,07 |
| Date Received | 2009-02-25 |
| Date of Report | 2009-01-28 |
| Date of Event | 2009-01-20 |
| Date Mfgr Received | 2009-01-28 |
| Date Added to Maude | 2009-06-26 |
| 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 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 | 2009-02-25 |
| Returned To Mfg | 2009-02-16 |
| Model Number | M00535700 |
| Catalog Number | 3570 |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 2009-02-25 |