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 2009-08-05 for TANDEM XL ERCP CANNULA M00535700 3570 manufactured by Boston Scientific Corp.
[1234302]
It was initially reported to boston scientific corporation on june 4, 2009 that a tandem xl ercp cannula device was used during a calculus removal procedure performed on (b)(6), 2009. According to the complainant, during preparation while the device was outside the patient, the physician was unable to insert the guidewire into this device due to resistance. The procedure was completed with same guidewire and another tandem xl ercp cannula device. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be good. This event has been deemed a mdr-reportable event based on the investigation results: the distal 5. 9 centimeters of the device was found to be partially collapsed including the radiopaque marker region.
Patient Sequence No: 1, Text Type: D, B5
[8369030]
Visual examination of the returned device revealed the working length had multiple bends in it. The distal 5. 9 centimeters of the device was found to be partially collapsed including the radiopaque marker region. A functional evaluation found that an 0. 035 inch guidewire could be passed up to a point 3 centimeters from the distal end of the device. The condition of the returned device was consistent with the event that the guidewire could not be advanced fully through the catheter. It appeared that during insertion of the device into the scope or use of the device, the distal tip was smashed, which did not allow the guidewire to pass. The most probable cause is operational context. The device history record for this lot was reviewed; no anomalies were noted. A search for similar complaints was completed and found no other complaints were associated with this lot. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2009-03716 |
| MDR Report Key | 1490382 |
| Report Source | 00,01,05,07 |
| Date Received | 2009-08-05 |
| Date of Report | 2009-07-10 |
| Date of Event | 2009-06-01 |
| Date Mfgr Received | 2009-07-10 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2010-04-15 |
| 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 CORP |
| 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 XL ERCP CANNULA |
| Product Code | ODD |
| Date Received | 2009-08-05 |
| Returned To Mfg | 2009-06-22 |
| Model Number | M00535700 |
| Catalog Number | 3570 |
| Lot Number | 12498442 |
| ID Number | NA |
| Device Expiration Date | 2011-03-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORP |
| Manufacturer Address | SPENCER IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-05 |