MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2002-10-21 for TANDEM XL ERCP CANNULA 3570 manufactured by A Division Of Boston Scientific Corp..
[19487804]
It was reported that during ercp procedure, the radiopaque tip detached from the catheter. Follow up indicated that the radiopaque tip was in the common bile duct (cbd). Several attempts were made to remove the tip from the cbd, but were unsuccessful. On further follow up it was learned that the radiopaque tip had migrated deeper into the cbd. The device was returned and retained by this manufacturer. The device was evaluated. The evaluation showed a badly damaged sheath with multiple bends and rips. The tip was viewed at 10x magnification and it was determined that no portion of the tip was missing. The radiopaque marker was view and a piece less than 0. 5 mm was found missing. The missing piece appears to be have been caused by a rubbing motion and all damage appears to have been done during use. No lot number was provided, therefore, a lot history search could not be performed. Of the two last lots shipped to the customer, there were no previous complaints. Co believes user technique, and/or patient anatomy may have contributed to this event. However, co is unable to determine the relationship between the device and the cause for this event, but appears to be from use of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000048-2002-00019 |
| MDR Report Key | 424344 |
| Report Source | 06,07 |
| Date Received | 2002-10-21 |
| Date of Report | 2002-09-11 |
| Date of Event | 2002-09-11 |
| Date Reported to FDA | 2002-10-21 |
| Date Mfgr Received | 2002-09-11 |
| Date Added to Maude | 2002-10-29 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | NANCY MICHAUD |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE |
| Manufacturer City | NATICK MA 01760153 |
| Manufacturer Country | US |
| Manufacturer Postal | 01760153 |
| Manufacturer Phone | 5086508349 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TANDEM XL ERCP CANNULA |
| Generic Name | ERCP CANNULA |
| Product Code | FGY |
| Date Received | 2002-10-21 |
| Returned To Mfg | 2002-09-24 |
| Model Number | NA |
| Catalog Number | 3570 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 413397 |
| Manufacturer | A DIVISION OF BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | 780 BROOKSIDE DRIVE SPENCER IN 47460 US |
| Baseline Brand Name | TANDEM XL ERCP CANNULA |
| Baseline Generic Name | ERCP CANNULA |
| Baseline Model No | NA |
| Baseline Catalog No | 3570 |
| Baseline ID | NA |
| Baseline Device Family | ERCP CANNULA |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K833417 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-10-21 |