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 2020-03-12 for CRE PRO GI M00558790 5879 manufactured by Boston Scientific Corporation.
[183382801]
(b)(6). (b)(4). A visual examination of the returned complaint device found that the balloon and the catheter did not have any visual defects and was in a good condition. Functional evaluation was performed and the balloon was inflated without problem; however, the balloon would not hold pressure due to a pinhole located at the proximal section of the shoulders of the balloon. A labeling review was performed and from the information available, this device was not used per the directions for use (dfu)/product label as the device was pre-inflated. It is possible that the balloon being inflated prior to use could have caused the damage found in the balloon, thereby affecting the performance and intended purpose of the device and leading to in an inability to use it during the procedure. Based on the condition and evaluation of the returned device, the most probable root cause is failure to follow instructions since the problem was traced to the user not following the manufacturer's instructions. 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
[183382802]
It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used during a gastrointestinal dilatation procedure performed in the esophagus on (b)(6) 2019. According to the complainant, during the preparation, an attempt to inflate the balloon was made; however, the balloon would not inflate. The procedure was completed with another cre pro gi wireguided dilatation balloon. There were no patient complications reported as a result of this event. 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 | 3005099803-2020-00768 |
| MDR Report Key | 9826531 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-12-26 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2019-06-28 |
| Date Added to Maude | 2020-03-12 |
| 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 GI |
| Generic Name | DILATOR, ESOPHAGEAL |
| Product Code | KNQ |
| Date Received | 2020-03-12 |
| Returned To Mfg | 2020-01-15 |
| Model Number | M00558790 |
| Catalog Number | 5879 |
| Lot Number | 0024029207 |
| 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 | 2020-03-12 |