MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-05-20 for RX LOCKING DEVICE AND BIOPSY CAP M00545260 4526S manufactured by Boston Scientific Corporation.
[145499709]
(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
[145499710]
It was reported to boston scientific corporation that an rx locking device biopsy cap was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019. According to the complainant, during the procedure, a dreamtome was fed through the port of the biopsy cap and met resistance. The scope was removed from the patient and it was noted that the sponge from the biopsy cap had detached and was pushed into the biopsy channel. The sponge was removed from the scope using pediatric forceps. It was reported that a water soluble lubricant was applied to the top of the biopsy cap, prior to use. The procedure was completed with a different scope and using another rx locking device 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 | 3005099803-2019-02551 |
| MDR Report Key | 8623340 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-20 |
| Date of Report | 2019-05-20 |
| Date of Event | 2019-03-28 |
| Date Mfgr Received | 2019-04-23 |
| Device Manufacturer Date | 2018-10-19 |
| Date Added to Maude | 2019-05-20 |
| 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 | 2019-05-20 |
| Model Number | M00545260 |
| Catalog Number | 4526S |
| Lot Number | 0022804700 |
| 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 | 2019-05-20 |