MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2008-09-12 for CRE ESOPHGEAL/PYLORIC/COLONIC WIREGUIDED BALLOON DILATION CATHETER M00558490 5849 manufactured by Boston Scientific.
[16652166]
.
Patient Sequence No: 1, Text Type: N, H10
[16700610]
It was reported that during a gastroscopy procedure the balloon was torn. The target stricture was in the esophagus. A 15-18mm/240cm/5. 5 f/g cre wireguided balloon dilation catheter had been advanced to the target stricture. During inflation, the balloon "tore" and subsequently "leaked" and failed to inflate. The procedure was completed with another of the same device. There were no pt complications reported with the pt's current condition listed as "stable".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2008-04508 |
| MDR Report Key | 1159523 |
| Report Source | 01,05,07 |
| Date Received | 2008-09-12 |
| Date of Report | 2008-08-20 |
| Date of Event | 2008-08-18 |
| Date Mfgr Received | 2008-08-20 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2008-12-05 |
| 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 | KEN HIRAKAWA |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836264 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORK LTD. |
| Manufacturer Street | CORK BUSINESS & TECHNOLOGY PK MODEL FARM ROAD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRE ESOPHGEAL/PYLORIC/COLONIC WIREGUIDED BALLOON DILATION CATHETER |
| Product Code | KNG |
| Date Received | 2008-09-12 |
| Returned To Mfg | 2008-09-04 |
| Model Number | M00558490 |
| Catalog Number | 5849 |
| Lot Number | 11724967 |
| Device Expiration Date | 2011-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1304557 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-12 |