MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ZERO TIP¿; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	M0063901010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a zero tip¿ basket was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2018.According to the complainant, during procedure, the wire from the handle was found to be broken.The procedure was completed with a different device.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 fine.
Additional Manufacturer Narrative
A visual analysis of the returned device found that the working length (including the sheath and the pull wire) was broken at the proximal section near the heat shrink at the handle section, consequently, confirming the reported complaint.It is the most likely that the device could have been excessively manipulated since the failure found (working length broken), is an issue that could have been generated by excessive manipulation of the device by the user or excess of force applied to the product prior to the procedure, excess of force can cause damages or deformities.Therefore, the most probable root cause of this complaint is ¿handling damage".A review of the device history record (dhr) was performed and no deviation was found.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a zero tip¿ basket was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2018.According to the complainant, during procedure, the wire from the handle was found to be broken.The procedure was completed with a different device.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 fine.

• Brand Name: ZERO TIP¿
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7343331
• Report Number: 3005099803-2018-00812
• Device Sequence Number: 19108286
• Product Code: FFL
• UDI-Device Identifier: 08714729342007
• UDI-Public: 08714729342007
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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): 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: M0063901010
• Device Catalogue Number: 390-101
• Device Lot Number: 0019039526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 03/15/2018
• Supplement Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR