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 2019-01-28 for RX LOCKING DEVICE AND BIOPSY CAP M00545260 4526S manufactured by Boston Scientific Corporation.
[134210801]
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18. The exact date of the event is unknown. The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event. The complainant was unable to provide the suspect device lot number; therefore, the expiration and device manufacture dates are unknown. (b)(4). The complainant indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[134210802]
It was reported to boston scientific corporation that an rx locking device biopsy cap was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure on an unknown date. According to the complainant, at the completion of the procedure during the post-procedure bedside clean, detergent was being injected down the working channel of the scope and it was noted that the sponge had detached and advanced down the biopsy channel. The procedure was completed using this biopsy cap. 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 | 3005099803-2019-00276 |
| MDR Report Key | 8281519 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-28 |
| Date of Report | 2019-01-28 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-01-04 |
| Date Added to Maude | 2019-01-28 |
| 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 | 100 BOSTON SCIENTIFIC WAY , |
| Manufacturer City | MARLBOROUGH MA 017521242 |
| Manufacturer Country | US |
| Manufacturer Postal | 017521242 |
| 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 | 2019-01-28 |
| Model Number | M00545260 |
| Catalog Number | 4526S |
| 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 | 100 BOSTON SCIENTIFIC WAY , MARLBOROUGH MA 017521242 US 017521242 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-28 |