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

Model Number	M0063901000
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	10/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(6).A visual analysis of the returned device found that the basket was in the closed/ retracted position when received.The sheath was found stretched and ripped/torn at the distal end.A functional test was performed by having the handle actuated, and it was found that the basket was not able to open due to the condition of the sheath being stretched.The evaluation concluded that during the procedure excessive manipulation of the device and interaction with the scope or other devices most likely contributed to the failures of sheath stretched and ripped/torn at the distal end.Additionally, anatomical and/or procedural factors encountered during the procedure could have increased the resistance within the working length causing damage to the sheath.The device¿s condition of sheath stretched directly affected the ability of the device to open the basket.Therefore, the most probable root cause of this complaint is operational context.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.The device history record (dhr) review found the device met all manufacturing specifications.A search of the complaint database confirmed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that an zero tip stone retrieval basket was used in the right ureter during a ureteral lithotripsy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, after removing ureteral stones several times, the basket failed to open outside the patient.Another zero tip basket was used to complete the procedure.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results; sheath torn/ split at the distal end.

• 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: 7207617
• Report Number: 3005099803-2018-00086
• Device Sequence Number: 19151613
• Product Code: FFL
• UDI-Device Identifier: 08714729341994
• UDI-Public: 08714729341994
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 01/04/2018

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: 10/31/2018
• Device Model Number: M0063901000
• Device Catalogue Number: 390-100
• Device Lot Number: 18570416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2018
• Initial Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1