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

Model Number M0063901050

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a zero tip nitinol retrieval basket was used during a lithotripsy stone removal procedure in the ureter performed on (b)(6) 2014.According to the complainant, during the procedure, a tip of one of the basket wires came loose and was left inside the patient.The procedure was completed with this device.A few days later, the patient had undergone an ureteroscopy and stent removal procedure.A stone removal basket, forceps, and flexible ureteroscope (manufacturers unknown), were used in attempt to retrieve the detached basket wire tip, however, the surgeon is not sure that the broken tip of the basket wire was retrieved successfully.No patient complications were reported after either procedure.The patient was admitted to the intensive care unit for observation as a precaution, and was released on (b)(6) 2014.The physician plans to follow-up with a ct scan in four months.

Manufacturer Narrative

(b)(4) for the reported event of tip of basket wire detached.The device has not been received for analysis.Upon receipt and 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.

• Brand Name: ZERO TIP?
• 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: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3754671
• MDR Text Key: 18310971
• Report Number: 3005099803-2014-01702
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2015
• Device Model Number: M0063901050
• Device Catalogue Number: 390-105
• Device Lot Number: 16397279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2014
• Initial Date FDA Received: 04/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2013
• 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 Outcome(s): Other