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 2018-02-16 for STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL M0063903200 390-320 manufactured by Boston Scientific - Marlborough.
[100315944]
(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
[100315945]
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the ureter during a transurethral lithotripsy (tul) procedure performed on (b)(6) 2018. According to the complainant, upon withdrawal, the coil part of the stone cone device was detached and fell into the kidney pelvis. The detached piece was successfully retrieved from the patient using forceps. The procedure was completed with this device. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[114217952]
Visual evaluation revealed that the coil was returned separated from the device. Burn marks were found in various places on the coil and a burn mark at the break causing the coating to fray. Therefore, the most probable root cause for this event is "caused by other device" since investigation indicates another device caused the complaint event. The device history record (dhr) review found the device met all manufacturing specifications. A search of the complaint database revealed that no similar complaints exist for the specified lot. A labeling review was performed and no anomalies were found.
Patient Sequence No: 1, Text Type: N, H10
[114217953]
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the ureter during a transurethral lithotripsy (tul) procedure performed on (b)(6) 2018. According to the complainant, upon withdrawal, the coil part of the stone cone device was detached and fell into the kidney pelvis. The detached piece was successfully retrieved from the patient using forceps. The procedure was completed with this device. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-00450 |
| MDR Report Key | 7278273 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-16 |
| Date of Report | 2018-01-31 |
| Date of Event | 2018-01-30 |
| Date Mfgr Received | 2018-03-09 |
| Device Manufacturer Date | 2017-10-03 |
| Date Added to Maude | 2018-02-16 |
| 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 | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL |
| Generic Name | DISLODGER, STONE, FLEXIBLE |
| Product Code | FGO |
| Date Received | 2018-02-16 |
| Returned To Mfg | 2018-02-06 |
| Model Number | M0063903200 |
| Catalog Number | 390-320 |
| Lot Number | 0003929695 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-16 |