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 2019-03-11 for CRE PULMONARY M00550310 5031 manufactured by Boston Scientific Corporation.
[138439962]
(b)(6). Investigation result: a visual examination of the returned complaint device revealed the balloon was torn circumferentially. Functional analysis could not be performed due to the condition of the device. This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its 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
[138439963]
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used during an airway dilation procedure performed on (b)(6) 2019. According to the complainant, during the procedure, the balloon burst. The procedure was completed with another cre pulmonary dilatation balloon. There have been no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01058 |
| MDR Report Key | 8409459 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-11 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-01-21 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2017-06-13 |
| Date Added to Maude | 2019-03-11 |
| 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 PULMONARY |
| Generic Name | BRONCHOSCOPE ACCESSORY |
| Product Code | KTI |
| Date Received | 2019-03-11 |
| Returned To Mfg | 2019-02-27 |
| Model Number | M00550310 |
| Catalog Number | 5031 |
| Lot Number | 20731202 |
| 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 | 200 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-11 |