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 2009-07-07 for TANDEM XL ERCP CANNULA M00535700 3570 manufactured by Boston Scientific Corporation.
[1262487]
Note: this report pertains to one of two events that occurred during the same procedure. Refer to mfr report # 3005099803-2009-03186 for the other associated device info. It was reported to boston scientific corp that a tandem xl ercp cannula and a hydra jagwire guidewire were used during a stent placement procedure performed on (b)(6), 2009 (pt over 18 years old). According to the complainant, while attempting to access the cystic duct, the ptfe coating of the jagwire detached into the cannula which made it impossible to advance the device. No coating detached in the pt as the fragments remained encapsulated in the cannula. The cannula and guidewire were removed. The procedure was completed with another tandem cannula and jagwire. 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 fine. The site later indicated that no device damage was visible at preparation. Also, no resistance was encountered when the guidewire was initially advanced.
Patient Sequence No: 1, Text Type: D, B5
[8314376]
(b)(4). The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device mfr dates are unk. The device has been rec'd from 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 | 3005099803-2009-03185 |
| MDR Report Key | 1476597 |
| Report Source | 00,01,05,07 |
| Date Received | 2009-07-07 |
| Date of Report | 2009-06-08 |
| Date of Event | 2009-06-08 |
| Date Mfgr Received | 2009-06-08 |
| 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 BROOKSDIE 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 | 2009-07-07 |
| Returned To Mfg | 2009-06-19 |
| 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 | 2009-07-07 |