MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06 report with the FDA on 2009-07-14 for TANDEM RX CANNULA M00545820 4582 manufactured by Boston Scientific Corporation.
[17017856]
It was reported to boston scientific corp on 06/19/2009, that a tandem rex cannula was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in 2009. According to the complainant, an ercp was completed with this device. A lithotripsy procedure was then performed with another device and a retrieval balloon. Following the lithotripsy, a contrast test was conducted and it was noticed that ro marker of the cannula remained in the bile duct. The physician indicated he was concerned that the ro marker remained in the duct. However, the procedure was completed at that time. Another procedure was rescheduled for one week later, for retrieval of the marker. On that day, the pt underwent a contrast test. The ro marker was not found. The physician indicated that the ro marker had most likely been eliminated via normal peristalsis. The pt's condition at the conclusion of the procedure was reported to be good.
Patient Sequence No: 1, Text Type: D, B5
[17235828]
The complainant was unable to provide the suspect device lot number; therefore, the device manufacture and expiration dates are unknown. 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 info from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2009-03307 |
| MDR Report Key | 1413952 |
| Report Source | 00,01,05,06 |
| Date Received | 2009-07-14 |
| Date of Report | 2009-06-19 |
| Date of Event | 2009-06-17 |
| Date Mfgr Received | 2009-06-19 |
| Date Added to Maude | 2009-07-20 |
| 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 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 RX CANNULA |
| Product Code | NML |
| Date Received | 2009-07-14 |
| Returned To Mfg | 2009-07-09 |
| Model Number | M00545820 |
| Catalog Number | 4582 |
| 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 | 1. Other | 2009-07-14 |