MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL; DISLODGER, STONE, FLEXIBLE

Model Number	M0063903100
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used during a ureteroscopy (urs) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the device broke inside the patient.The detached part was successfully retrieved using endoscopic forceps.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be well.
Additional Manufacturer Narrative
A visual analysis of the returned device revealed that the distal stop and distal end of the coil is detached and was not returned.Additionally, a burn mark was noted on the blue green shrink indicating that the device was scorched.The device shows evidence of scorching, which is most likely caused by the lithotripsy procedure.Therefore, the root cause of this complaint is caused by other device.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 anomaly was found.
Event or Problem Description
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used during a ureteroscopy (urs) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the device broke inside the patient.The detached part was successfully retrieved using endoscopic forceps.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be well.

• Brand Name: STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL
• Common Device Name: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 6123604
• Report Number: 3005099803-2016-03613
• Device Sequence Number: 627110
• Product Code: FGO
• UDI-Device Identifier: 08714729430209
• UDI-Public: (01)08714729430209(17)20161031(10)B80619
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: M0063903100
• Device Catalogue Number: 390-310
• Device Lot Number: B80619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/23/2016
• Supplement Report FDA Received Date: 04/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR