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

Model Number	5640
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One-unit model 5640 turnpike spiral catheter was returned to vsi for evaluation.A manufacturing record review was completed and zero nonconformance's were found related to this lot therefore supporting the device met material, assembly and performance specifications.A returned product evaluation was also completed and confirmed the failure.The distal tip section of the catheter was completely separated and was missing from the returned device.There were "sanding" marks on the distal portion of the catheter which is consistent with rotating against calcification.The separation was most likely caused by torquing the catheter with the tip fixed.
Event or Problem Description
Physician had a separation of the entire tip of the catheter.Additional information received 15jan19: the tip was irretrievable.The physician was performing an intervention to try and open the patients 1st diagonal branch (unsuccessfully).The physician stated they were running a turnpike spiral over a wire.There is no follow-up procedure planned.The patient is reported as stable and there were no negative complications secondary to this event.No impact to patient reported.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8278756
• Report Number: 2134812-2019-00008
• Device Sequence Number: 1692029
• Product Code: DQY
• UDI-Device Identifier: M20656400
• UDI-Public: M20656400
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/14/2019

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: 12/04/2020
• Device Model Number: 5640
• Device Lot Number: 638494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 96