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

Model Number	5639
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	10/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturing record review was completed and zero nonconformances were found, supporting the fact the device met material, assembly and performance specifications.There was no returned product for this complaint.A non-conformance was initiated to further investigate this issue and document any applicable corrections.
Event or Problem Description
Physician had a very difficult retrograde cto case and used the turnpike lp 150 to access the collateral branches.While spinning the catheter in both directions, the hub of the turnpike lp 150 broke off.Spent an hour an a half working on getting the catheter out with out losing their wire placement.The catheter came out, however, not in one piece.Physician had to cut it to remove catheter w/o losing wire.
Additional Manufacturer Narrative
The returned product evaluation confirmed the event.The catheter shaft had separated under the strain relief.Further investigation found it is likely that the catheter coils underneath the strain relief were disturbed during the hub and strain relief molding process.An internal corrective action is associated to this event to address the issue.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8080198
• Report Number: 2134812-2018-00084
• Device Sequence Number: 13859082
• Product Code: DQY
• UDI-Device Identifier: M20656390
• UDI-Public: +M20656390/$$32009066325943
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 10/22/2018

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: 09/06/2020
• Device Model Number: 5639
• Device Lot Number: 632594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 12/21/2018
• 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
• Patient Age: 86 YR