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

Model Number	M0063801120
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual analysis of the returned device revealed that the basket was in an open position when received.Additionally, the sheath was found torn at the distal end and the basket wires were bent.The evaluation concluded that during preparation the device could have been manipulated, since the failures found sheath torn at the distal end and basket wires bent are issues that could have been generated due to the interaction with the scope, interacting with other devices or due to manipulation.Therefore the most probable root cause of this complaint is handling damage.The review of the device history record (dhr) was performed and no anomalies were found.A search of the database confirmed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a segura hemisphere¿ basket was used in the biliary tract during stone management procedure performed on (b)(6) 2016.According to the complainant, during preparation, the basket was unable to open.The procedure was completed with another segura hemisphere¿ basket.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 stable.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the sheath was found torn at the distal end.

• Brand Name: SEGURA HEMISPHERE¿
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6153230
• Report Number: 3005099803-2016-03776
• Device Sequence Number: 10963284
• Product Code: FFL
• UDI-Device Identifier: 08714729341949
• UDI-Public: (01)08714729341949(17)20170729(10)17162303
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 11/17/2016

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: 07/29/2017
• Device Model Number: M0063801120
• Device Catalogue Number: 380-112
• Device Lot Number: 17162303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2016
• Initial Report FDA Received Date: 12/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 55