MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER 8/10 DILATOR/SHEATH SET; DILATOR, CATHETER, URETERAL

Model Number M0062601200

Device Problem Torn Material (3024)

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

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an 8/10 dilator/sheath set was used during a percutaneous nephrolithotomy procedure.According to the complainant, after the procedure, the nurse noticed that the device was buckled and the 10fr outer sheath was torn when she was placing it back on the table.The procedure was completed with another of the same device.The condition of the patient was reported to be stable at the conclusion of the procedure.

• Brand Name: 8/10 DILATOR/SHEATH SET
• Type of Device: DILATOR, CATHETER, URETERAL
• 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: 3822439
• MDR Text Key: 4399203
• Report Number: 3005099803-2014-02035
• Device Sequence Number: 1
• Product Code: EZN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K851144
• 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: 04/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: M0062601200
• Device Catalogue Number: 260-120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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