MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-16 for BOSTON SCIENTIFIC M00622610 2261 manufactured by Boston Scientific.
[4418473]
Pt admitted with non-stemi mi and an intermittent gi bleed, with guaiac positive stool. The pt underwent an urgent endoscopy under general anesthesia as h/h dropped. The endoscopy revealed evidence of an oozing duodenal ulcer. The physician decided to clip the bleeders. When the clip opened, the tip fell off. Another device had to be obtained, the clips were applied and the procedure completed. Although there was no harm to the pt, the device was defective resulting in a delay (inter-procedural with general anesthesia).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5035726 |
| MDR Report Key | 3763578 |
| Date Received | 2014-04-16 |
| Date of Report | 2014-04-16 |
| Date of Event | 2014-03-18 |
| Date Added to Maude | 2014-04-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOSTON SCIENTIFIC |
| Generic Name | RESOLUTION CLIP |
| Product Code | HCH |
| Date Received | 2014-04-16 |
| Model Number | M00622610 |
| Catalog Number | 2261 |
| Lot Number | ML000626C3 |
| Device Expiration Date | 2016-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | ONE BOSTON SCIENTIFIC PLACE NATICK MA 01760133 US 01760 1337 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-04-16 |