MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTROLWIRE; WIRE, GUIDE, CATHETER

Model Number H 74939216930010

Device Problem Component Missing (2306)

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

Event Date 05/10/2016

Event Type  malfunction  

Event Description

The patient was undergoing a bilateral common and external iliac stenting when the v-14 guidewire was removed.The scrub tech and surgeon noticed the tip of the guidewire was missing.

• Brand Name: CONTROLWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 5905 nathan lane; plymouth MN 55442
• MDR Report Key: 6092517
• MDR Text Key: 59633832
• Report Number: 6092517
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/21/2018
• Device Model Number: H 74939216930010
• Device Lot Number: 19173753
• Other Device ID Number: V-14, 190 CM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 82