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 PRO M00558710 5871 manufactured by Boston Scientific Corporation.
[185197602]
(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 encountered during the procedure, such as handling of the device, the technique used by the physician, the interaction between the scope, and normal procedural difficulties encountered during the procedure, that could have affected device performance and its intended purpose. 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
[185197603]
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used during an esophageal dilation procedure performed on december 9, 2019. According to the complainant, during the procedure, it was noted that the balloon would not inflate and seemed to be leaking. The procedure was completed at this time. There were no patient complications reported as a result of this event. The patient condition at the conclusion of the procedure was reported to be okay. Investigation results revealed that the balloon found a pinhole; therefore, this is now an mdr reportable event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-01225 |
| MDR Report Key | 9883054 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-10-21 |
| 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 PRO |
| Generic Name | CATHETER, BILIARY, DIAGNOSTIC |
| Product Code | FGE |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-01-31 |
| Model Number | M00558710 |
| Catalog Number | 5871 |
| Lot Number | 0024629563 |
| 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 |