MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-09-26 for RX LOCKING DEVICE AND BIOPSY CAP M00545260 48045 manufactured by Boston Scientific Corporation.
[121865179]
Patient's exact age is unknown; however it was reported that the patient was over the age of 18. No event date was given, therefore an approximate date of (b)(6) 2018 was used as the event date. The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[121865180]
It was reported to boston scientific corporation that a rx locking device and biopsy cap was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date. According to the complainant, during the procedure and outside the patient, the sponge was detached from the biopsy cap and was lodge inside the working channel of the scope. An attempt to remove the sponge was performed by pushing two autotomies through the working channel but failed. The sponge was finally remove from the endoscope channel by flushing with scope buddy. The procedure was completed with another rx locking device and 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 | 3005099803-2018-60607 |
| MDR Report Key | 7911453 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-26 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-09-24 |
| Date Mfgr Received | 2018-09-05 |
| Date Added to Maude | 2018-09-26 |
| 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 | 2018-09-26 |
| Model Number | M00545260 |
| Catalog Number | 48045 |
| 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 | 2018-09-26 |