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

Model Number M0063301080

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2015

Event Type  malfunction  

Manufacturer Narrative

Visual examination of the returned device found the basket sub-assembly was detached at the splice cannula.The basket and all the basket wires were present and attached.The basket was bent.The detached fragment of the distal end of the wire sub-assembly was also returned.The detached fragment was bent in two locations.The outer sheath was found bent and kinked in several locations.The introducer was not returned.A functional evaluation was performed and found that the handle operation was smooth and the sheath moved freely over the wire.The evaluation concluded that the condition of the returned unit was not consistent with the complaint incident that the sheath torn/split.The wire sub-assembly was found detached at the splice cannula.The wire sub-assembly splice joints are 100% inspected during manufacturing.It was not possible to determine the amount of force that was exerted on the wire sub-assembly to cause it to break.Therefore, the most probable root cause is ¿undeterminable.¿ the device history record review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a gemini stone retrieval basket was use in the ureter during a ureterolythotripsy procedure performed on (b)(6) 2015.According to the complainant, during unpacking, the sheath was found torn/split.The procedure was completed with another gemini stone retrieval 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.This event has been deemed a reportable event based on the investigation results; basket detached.

• Brand Name: GEMINI¿
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5611673
• MDR Text Key: 43778447
• Report Number: 3005099803-2016-01030
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: M0063301080
• Device Catalogue Number: 330-108
• Device Lot Number: 17928359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 28 YR