MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-03 for CRE M00558380 manufactured by Boston Scientific Corporation.
[44212124]
Patient Sequence No: 1, Text Type: N, H10
[44212125]
The first balloon dilator (lot# 18884819) that was used did not go all the way through the biopsy channel. It was tried twice with no success. The balloon catheter would get jammed/stuck in the scope. The catheter was removed and a new catheter was used to dilate esophagus. The second balloon catheter (lot# 18846982) would not deflate 100% for it to be removed safely through the scope. The scope had to be removed from the patient and the balloon portion of the catheter was cut/separated from the rest of the catheter. The remaining part of the balloon catheter was safely removed from scope. The procedure was able to be completed with a new catheter with no complications to the patient. Manufacturer response for esophageal balloon catheter, cre esophageal fixed wire 18-20 (per site reporter): sent 2 replacements. Obtained information for their report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5624471 |
| MDR Report Key | 5624471 |
| Date Received | 2016-05-03 |
| Date of Report | 2016-04-19 |
| Date of Event | 2016-03-29 |
| Report Date | 2016-04-19 |
| Date Reported to FDA | 2016-04-19 |
| Date Reported to Mfgr | 2016-04-19 |
| Date Added to Maude | 2016-05-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRE |
| Generic Name | DILATOR, ESOPHAGEAL |
| Product Code | KCF |
| Date Received | 2016-05-03 |
| Returned To Mfg | 2016-04-19 |
| Catalog Number | M00558380 |
| Lot Number | 18884819 |
| Device Expiration Date | 2018-02-28 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH, MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-03 |