MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06 report with the FDA on 2009-05-05 for TANDEM RX CANNULA M00545820 4582 manufactured by Boston Scientific Corporation.
[1190022]
It was reported to boston scientific corporation in 2009, that a tandem rx cannula was used during a stone retrieval procedure. According to the complainant, the procedure was performed with a combination of products including the tandem rx cannula. Another manufacturer's stone retrieval device was used for the stone removal. However, the basket could not be removed from the scope. Therefore, the scope was removed from the patient, but the basket wire remained inside the patient's body. The scope was reinserted without problem. The rx cannula was used, however, cannulation was unsuccessful with this device. Upon removal of the cannula, it was observed that the ro marker was missing. Another manufacturer's device was used to perform the cannulation. The stone and the basket were successfully removed. The physician felt the ro marker would be eliminated on its own. No patient complications were reported as a result of this event. At the conclusion of the procedure, the patient's condition was reported to be good.
Patient Sequence No: 1, Text Type: D, B5
[8278475]
According to the complainant, the suspect device has been disposed of and is not available for return. A device evaluation cannot be performed; the cause of the reported malfunction is undetermined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2009-02241 |
| MDR Report Key | 1429004 |
| Report Source | 00,01,05,06 |
| Date Received | 2009-05-05 |
| Date of Report | 2009-04-06 |
| Date of Event | 2009-04-03 |
| Date Mfgr Received | 2009-04-06 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2009-09-02 |
| 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 | 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 CORPORATION |
| 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 RX CANNULA |
| Product Code | ODD |
| Date Received | 2009-05-05 |
| Model Number | M00545820 |
| Catalog Number | 4582 |
| Lot Number | 12320542 |
| ID Number | NA |
| Device Expiration Date | 2011-01-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | SPENCER IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-05-05 |