MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-01-16 for JAGTOME RX 44 CANNULATING SPHINCTEROTOME M00573060 7306 manufactured by Boston Scientific Corporation.
[20157757]
It was reported to boston scientific corporation in late 2008 that a jagtome rx 44 cannulating sphincterotome was used during a procedure. According to the complainant, "the jagtome would not extend and flex completely, and there seemed to be a delay in response of the tome while the tome was in the small bowel. "
Patient Sequence No: 1, Text Type: D, B5
[20401287]
Other (would not extend and flex completely, delay in response). According to the complainant, the suspect device 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 | 3005099803-2009-00235 |
| MDR Report Key | 1326148 |
| Report Source | 07 |
| Date Received | 2009-01-16 |
| Date of Report | 2008-12-18 |
| Date Mfgr Received | 2008-12-18 |
| Device Manufacturer Date | 2008-08-01 |
| Date Added to Maude | 2009-05-28 |
| 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 | JAGTOME RX 44 CANNULATING SPHINCTEROTOME |
| Product Code | ODD |
| Date Received | 2009-01-16 |
| Model Number | M00573060 |
| Catalog Number | 7306 |
| Lot Number | 11961798 |
| ID Number | NA |
| Device Expiration Date | 2011-08-19 |
| 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 | 2009-01-16 |