MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2000-05-26 for TANDEM XL ERCP CANNULA 3570 manufactured by Microvasive Endoscopy, A Div Of Boston Scientific Corp..
[168166]
It was reported that during an ercp procedure, a piece of the tip of the device was noticed to have broken off and migrated to the common bile duct. The product was returned for evaluation. A visual evaluation revealed that a very small piece of the distal tip of the catheter was missing. It appears that the tip of the catheter has been scraped against something sharp to cause the small piece to detach.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000048-2000-00023 |
| MDR Report Key | 279334 |
| Report Source | 07,08 |
| Date Received | 2000-05-26 |
| Date of Report | 2000-05-25 |
| Date of Event | 2000-03-01 |
| Date Mfgr Received | 2000-03-22 |
| Device Manufacturer Date | 1999-12-01 |
| Date Added to Maude | 2000-05-30 |
| 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 | 3 |
| Manufacturer Contact | JOSEPH CURTIS |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE |
| Manufacturer City | NATICK MA 01760153 |
| Manufacturer Country | US |
| Manufacturer Postal | 01760153 |
| Manufacturer Phone | 5086508181 |
| 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 | 2000-05-26 |
| Returned To Mfg | 2000-03-22 |
| Model Number | NA |
| Catalog Number | 3570 |
| Lot Number | 2853636 |
| ID Number | NA |
| Device Expiration Date | 2001-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 270350 |
| Manufacturer | MICROVASIVE ENDOSCOPY, A DIV 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 | 2000-05-26 |