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

Model Number M0063301110

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a gemini¿ stone retrieval basket was used during a cystoscopy, pyelogram and removal of ureter stone procedure performed on (b)(6) 2014.According to the complainant, during preparation, the basket did not open during testing before introducing it into the patient.The procedure was completed with another of the same 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 stable.Based on the investigation result of basket detached, this is now a reportable event.

Manufacturer Narrative

The complainant was unable to report the upn and lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.A visual analysis of the returned gemini basket revealed that the device was disassembled when it was received.The basket was detached at the splice joint.Approximately 3mm of the splice cannula remained on the proximal end of the broken wire attached to the basket.The detached fragment was kinked in several locations.The sheath was also kinked at the distal end.Additionally, dried residue was noted on the inside of distal end of the sheath, and the wire sub-assembly was found to be bent.The handle cap was removed from the handle when received, and there was a torque mark present on the handle cap to indicate proper torque during the assembly process.There were also prominent indentions on the pinch vise to indicate the handle cannula was properly placed during assembly.Based on the condition of the returned device and the evaluation conducted, the most probable root cause classification is undeterminable.

• 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: 4562900
• MDR Text Key: 17574576
• Report Number: 3005099803-2015-00459
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: ZA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2015

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
• Device Operator: Health Professional
• Device Model Number: M0063301110
• Device Catalogue Number: 330-111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2015
• Initial Date FDA Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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