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

Model Number	5639
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Embolism (4439); Insufficient Information (4580)
Date of Event	04/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing records will be reviewed.A follow-up report will be issued after the investigation is complete.
Event or Problem Description
As reported: during use on patient the catheter inserted down calcified rca and tip broke off and remained in the vessel.Multiple attempts have been made to obtain additional information have been unsuccessful.
Additional Manufacturer Narrative
One-unit of turnpike lp was returned for evaluation.A manufacturing record review was completed and no related nonconformances were found therefore, supporting the device met material, assembly and performance specifications.Blood particulates were found on the hub.No tip or shaft damages were observed on the catheter.Length, o.D at the proximal shaft, o.D at the distal shaft, and tip length were measured and found catheter met specification per drawing.No other damages observed.Case details were reviewed.The event description states that the tip broke when inserted down a calcified rca.A returned product evaluation was completed.No tip damage or separation was observed.No other shaft damages along the length of the catheter were noted.Additional information was requested on the procedure.No response was received.Additional clarification was requested on the returned device as no damages were noted.Account responded stating that device returned was a faulty unit.Based on the information and returned product evaluation, the most likely root cause of the issue is undeterminable.No product failure was noted with the turnpike lp.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 11799272
• Report Number: 2134812-2021-00043
• Device Sequence Number: 14498346
• Product Code: DQY
• UDI-Device Identifier: 20841156105058
• UDI-Public: (01)20841156105058
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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: No Information
• Device Expiration Date: 04/23/2022
• Device Model Number: 5639
• Device Lot Number: 671967
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1