MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC TURNPIKE SMOOTH; CATHETER

Model Number	5642
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One-unit model 5642 turnpike was returned to vsi for evaluation.A returned product evaluation was completed.The distal tip section of the catheter was severely damaged, and a portion of the tungsten tip material was missing.The catheter material near the separated tip was twisted and torn which is consistent with rotating against resistance.The most likely root cause is related to operational context and unintended user error.
Event or Problem Description
It was reported that the tip broke off in the coronary artery they were working on.The procedure was completed normally by placing stents.The tip was not removed from the body.It was stented over.There was no special procedure required from losing the tip.There was not vessel damage.No further complications were reported.

• Brand Name: TURNPIKE SMOOTH
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 9848116
• Report Number: 2134812-2020-00023
• Device Sequence Number: 764599
• Product Code: DQY
• UDI-Device Identifier: 10841156100728
• UDI-Public: (01)10841156100728
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151981
• 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): 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2021
• Device Model Number: 5642
• Device Catalogue Number: 5642
• Device Lot Number: 660926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/18/2020
• 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
• Patient Age: 70 YR
• Patient Weight: 90