MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC BANDIT GUIDEWIRE; CATHETER GUIDEWIRE

Model Number	7444
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation, however, images were provided.A manufacturing record review was completed and zero nonconformances were found therefore supporting the device met material, assembly and performance specifications.Based on the information provided stating the wire knuckled in a stent and became knotted, causing the coils to unravel/separate from the core wire, the most likely root cause for the damage is operational context (device interaction with stent).
Event or Problem Description
While physician was using the bandit guidewire, it knuckled in a stent.The wire became knotted when he knuckled it, and the coils uncoiled/separated from the core wire.The device remained intact and no pieces of the wire were left in the patient.

• Brand Name: BANDIT GUIDEWIRE
• Common Device Name: CATHETER GUIDEWIRE
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8006248
• Report Number: 2134812-2018-00077
• Device Sequence Number: 1150987
• Product Code: DQX
• UDI-Device Identifier: M20674440
• UDI-Public: M20674440
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/23/2020
• Device Model Number: 7444
• Device Lot Number: 632529
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention