MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-26 for CRE FIXED WIRE M00558360 5836 manufactured by Boston Scientific Corporation.
[185198136]
(b)(4). According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[185198137]
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used during an esophagogastroduodenoscopy (egd) procedure performed in the esophagus on february 28, 2020. According to the complainant, during the procedure, it was noted that the balloon could not be deflated and cannot be pulled out through the scope as it was stuck. The scope was then pulled out of the patient with the balloon still inside the scope. The procedure was completed at this time. There have been no patient complications reported as a result of this event. The patient condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-01228 |
| MDR Report Key | 9883061 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-12-05 |
| Date Added to Maude | 2020-03-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORK LIMITED |
| Manufacturer Street | CORK BUSINESS TECHNOLOGY PARK 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 FIXED WIRE |
| Generic Name | DILATOR, ESOPHAGEAL |
| Product Code | KNQ |
| Date Received | 2020-03-26 |
| Model Number | M00558360 |
| Catalog Number | 5836 |
| Lot Number | 0024878167 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |