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	Foreign Body In Patient (2687)
Date of Event	10/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Preliminary manufacturing record was reviewed, there were no nonconformance related to this lot, therefore, supporting the device met material, assembly and performance specifications.A follow-up report will be issued after the investigation is complete.
Event or Problem Description
As reported: tip separated, fell apart in use.Stented the tip to the vessel wall.It is reported it was a successful cto- vessel opened.
Additional Manufacturer Narrative
A manufacturing record review was completed and no related nonconformances were found.A returned product evaluation was completed.The entire 10mm tungsten loaded distal tip of the turnpike was separated.The point of separation was twisted, indicating that the catheter was torqued.The catheter shaft was also damaged.The damage was consistent with rotating the catheter against resistance.It is likely that the damage was caused by the rotation of the catheter while the distal tip section of the turnpike was trapped and not moving.The turnpike ifu warns; "do not rotate the catheter more than two (2) consecutive 360° rotations in either direction if the distal tip becomes lodged and is not also rotating, as it may result in separation of the catheter, damage to the catheter, or vessel injury.".

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 10743681
• Report Number: 2134812-2020-00089
• Device Sequence Number: 19695530
• Product Code: DQY
• UDI-Device Identifier: 10841156100698
• UDI-Public: (01)10841156100698
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K191560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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: 11/14/2021
• Device Model Number: 5639
• Device Catalogue Number: 5639
• Device Lot Number: 662145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 12/16/2020
• 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: 74 YR
• Patient Weight: 83