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 2009-05-27 for TANDUM XL BILIARY CANNULA M00535700 3570 manufactured by Boston Scientific Corporation-spencer.
[19684567]
It was reported to boston scientific corporation in 2008, that a tandem xl biliary cannula device was used for an enscopic retrograde cholangiopancreatography (ercp) procedure performed four days prior (patient age, gender, and weight are unknown). According to the complainant, during flushing, saline leaked from teh distal bond. The procedure was completed with another of the same tandum xl biliary 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. "
Patient Sequence No: 1, Text Type: D, B5
[19711155]
No consequences or impact to patient. Fluid leak(s). The device was evaluated for the reported failure. A visual evaluation found no apparent defects. A functional evaluation found that the guidewire could be passed through the device without issue. A leak was found at the proximal end of the heatshrink at the hub of the device. The evaluation confirmed the customer complaint. A review of the device history record (dhr) was performed; no anomalies were noted. A search for the complaint database revealed that no additional complaints exist for the specified lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-05623 |
| MDR Report Key | 1392926 |
| Report Source | 00,01,05,07 |
| Date Received | 2009-05-27 |
| Date of Report | 2008-06-16 |
| Date of Event | 2008-06-12 |
| Date Mfgr Received | 2008-06-16 |
| Device Manufacturer Date | 2008-03-24 |
| Date Added to Maude | 2009-05-27 |
| 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 | MR. 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-SPENCER |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| 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 | TANDUM XL BILIARY CANNULA |
| Generic Name | TANDUM XL BILIARY CANNULA, PRODUCT CODE: FGY |
| Product Code | ODD |
| Date Received | 2009-05-27 |
| Returned To Mfg | 2008-06-27 |
| Model Number | M00535700 |
| Catalog Number | 3570 |
| Lot Number | 11576373 |
| Device Expiration Date | 2010-03-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION-SPENCER |
| Manufacturer Address | 780 BROOKSIDE DRIVE SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-05-27 |