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 2020-03-31 for CRE PRO M00558610 5861 manufactured by Boston Scientific Corporation.
[185740304]
(b)(4). Although the suspect device has been received, the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[185740305]
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the sphincter of oddi during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020. According to the complainant, during the procedure, the balloon burst. The procedure was completed with another cre pro wireguided dilatation balloon. 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-01300 |
| MDR Report Key | 9904034 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-06-13 |
| Date Added to Maude | 2020-03-31 |
| 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 | 2020-03-31 |
| Returned To Mfg | 2020-03-23 |
| Model Number | M00558610 |
| Catalog Number | 5861 |
| Lot Number | 0023946518 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-31 |