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 2018-09-25 for RX LOCKING DEVICE AND BIOPSY CAP M00545260 48045 manufactured by Boston Scientific Corporation.
[121714249]
(b)(4). The device has not been received for analysis. Upon receipt and 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
[121714251]
It was reported to boston scientific corporation that an rx locking device and biopsy cap was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an (b)(6) 2018. According to the complainant, during the procedure, when an introducer of a guidewire was used to poke the entry of the biopsy cap, the sponge got detached and was stuck in the working channel of the scope. The procedure was completed with this device and the sponge was successfully removed by the technician during reprocessing of the scope. There was no serious injury nor adverse patient effects reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-60577 |
| MDR Report Key | 7907981 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-08-04 |
| Date Mfgr Received | 2018-08-30 |
| Device Manufacturer Date | 2018-06-14 |
| Date Added to Maude | 2018-09-25 |
| 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 CORPORATION |
| Manufacturer Street | 780 BROOKSIDE DRIVE , |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RX LOCKING DEVICE AND BIOPSY CAP |
| Generic Name | ENDOSCOPE AND/OR ACCESSORIES |
| Product Code | ODC |
| Date Received | 2018-09-25 |
| Model Number | M00545260 |
| Catalog Number | 48045 |
| Lot Number | 0022250333 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-09-25 |