MAUDE Adverse Event Report: BOSTON SCIENTIFIC STAINLESS STEEL GUIDEWIRE; ACCESSORIES, CATHETER

Catalog Number M001201080

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/08/2018

Event Type  Injury  

Event Description

Wire broke during access.At the end of the case, successfully snare the portion of the wire that was in the body.

• Brand Name: STAINLESS STEEL GUIDEWIRE
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC; palm springs CA 92262
• MDR Report Key: 7590830
• MDR Text Key: 110778742
• Report Number: MW5077743
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: M001201080
• Device Lot Number: 18415222
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR