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

Lot Number 21773340

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/10/2018

Event Type  malfunction  

Event Description

Doctor tried shaping the wire and wire wouldn't hold its shape.Another wire out of the same lot number was used and it worked fine.

• Brand Name: CHOICE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlbourgh MA 01752
• MDR Report Key: 7442520
• MDR Text Key: 105923162
• Report Number: 7442520
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/10/2018,04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/21/2020
• Device Lot Number: 21773340
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR