MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-07-14 for TANDEM XL ERCP CANNULA M00535700 3570 manufactured by Boston Scientific Corporation.
[16734867]
Note: the date of event is unk. It was reported to boston scientific corporation that a tandem xl ercp cannula was to be used during an ercp (endoscopic retrograde cholangiopancreatography) procedure. According to the complainant, while flushing pre-procedure, the device tip appeared as if it had been cut instead of tapered. The device was not used on the pt. The site also indicated that no damage was identified to the outside of the package. The procedure was completed with another tandem xl ercp cannula. There were no pt complication reported as a result of this event. The pt's condition at the conclusion of the procedure was reported to be okay.
Patient Sequence No: 1, Text Type: D, B5
[17055065]
(b)(4) - (tip appearance). The device has been received for analysis. Upon completion of the failure analysis of the complaint device, if there is any further relevant info from that review, a supplemental medwatch will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2009-03294 |
| MDR Report Key | 1480859 |
| Report Source | 05,07 |
| Date Received | 2009-07-14 |
| Date of Report | 2009-06-16 |
| Date Mfgr Received | 2009-06-16 |
| Device Manufacturer Date | 2009-04-01 |
| Date Added to Maude | 2010-04-10 |
| 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 | 2009-07-14 |
| Returned To Mfg | 2009-06-23 |
| Model Number | M00535700 |
| Catalog Number | 3570 |
| Lot Number | 12513233 |
| ID Number | NA |
| Device Expiration Date | 2011-03-31 |
| 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 | 2009-07-14 |