MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for CRE FIXED WIRE M00558370 5837 manufactured by Boston Scientific Corporation.
[185196957]
Date of event was approximated to (b)(6) 2019 as no event date was reported. (b)(4). Visual examination of the returned complaint device found the balloon did not show visual defects and looked normal. No damage found on the catheter of the device. Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to a pinhole in the distal section on the body of the balloon. This failure is likely due to factors or conditions related to the procedure that could have affected its performance and its intended purpose, such as the lesion characteristics, the manner in which the device was handled and manipulated and the technique used by the physician during the procedure. Therefore, the most probable root cause is adverse event related to procedure. A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Patient Sequence No: 1, Text Type: N, H10
[185196958]
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used during a procedure performed on an unknown date. According to the complainant, during the preparation, it was noted that there was a hole in the white connector part in the base of the delivery. The procedure was completed with another cre fixed wire dilatation balloon. No patient complications have been reported as a result of the event. Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts. Investigation results revealed that the balloon had a pinhole; therefore, this is now an mdr reportable event
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-01197 |
| MDR Report Key | 9883062 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-12-01 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-06-27 |
| 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 | 00 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 |
| Returned To Mfg | 2020-01-29 |
| Model Number | M00558370 |
| Catalog Number | 5837 |
| Lot Number | 0024021674 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 |