MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2006-10-06 for TANDEM XL ERCP CANNULA * 3570 manufactured by Boston Scientific.
[662052]
The complainant has reported that a pt (age and gender unk) underwent a therapeutic procedure in 2006. It was reported that during the procedure, "the blue material (paint) at the distal of this device was detached and fallen off near the duodenal papilla. This material was aspirated by the scope, but it was not all materials. Even though some materials remained in the duodenal, the physician thought these materials would not be adverse to the pt. " the procedure outcome was not provided. There was no reported complication or ill effect sustained by the pt.
Patient Sequence No: 1, Text Type: D, B5
[7981640]
This device has not been received by this manufacturer. Therefore, a failure analysis is not available and we are unable to determine the relationship between this device and the cause for this event. Should further relevant details become available a supplemental medwatch report will be filed under the appropriate sequence number. Our directions for use outline appropriate placement, access and maintenance procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000048-2006-00518 |
| MDR Report Key | 863749 |
| Report Source | 01,05,06,07 |
| Date Received | 2006-10-06 |
| Date of Report | 2006-10-02 |
| Date of Event | 2006-10-02 |
| Date Mfgr Received | 2006-10-02 |
| Device Manufacturer Date | 2006-07-01 |
| Date Added to Maude | 2007-06-12 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | KEN HIRAKAWA |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE |
| Manufacturer City | NATICK MA 01760 |
| Manufacturer Country | US |
| Manufacturer Postal | 01760 |
| Manufacturer Phone | 5086836264 |
| Manufacturer G1 | BOSTON SCIENTIFIC |
| Manufacturer Street | 760 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 XL ERCP CANNULA |
| Generic Name | CANNULATION |
| Product Code | FGY |
| Date Received | 2006-10-06 |
| Model Number | * |
| Catalog Number | 3570 |
| Lot Number | 8896622 |
| ID Number | * |
| Device Expiration Date | 2008-07-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 846106 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | 780 BROOKSIDE DR. SPENCER IN 47460 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-06 |