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

Model Number	5638
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/04/2022
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: tip fracture.Doctor was able to trap and remove the broken piece of the tip from the lad.
Additional Manufacturer Narrative
One-unit of the turnpike lp was returned for evaluation.Blood particulates were noted on the catheter.The tip was observed to be separated.Approximately 5 mm tip was separated.The separated tip material was structurally damaged.No other issues noted.The device history record was reviewed and indicated no non-conformities related to this lot, therefore, supporting the device met material, assembly, and performance specifications prior to shipment.The event description states that the tip fractured.The damages are likely to have occurred during use in the procedure.Per ifu states the following warning and precaution: never advance, withdraw, or rotate an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter or guidewire against resistance may result in separation of the catheter or guidewire tip, other device damage, or vessel injury.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 additional information was requested from the account.No response was received.It is likely that the tip was caught against a calcified lesion and subjected to damages when advanced/rotated.The physician was able to trap and remove the broken piece of the tip from lad.Procedure was aborted.Based on the information, the most likely root cause of the issue is operational context and/or unintended use error.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: angela meister ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564253
• MDR Report Key: 13564130
• Report Number: 2134812-2022-00021
• Device Sequence Number: 1969328
• Product Code: DQY
• UDI-Device Identifier: 10841156105044
• UDI-Public: 10841156105044
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2022

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: 10/28/2023
• Device Model Number: 5638
• Device Catalogue Number: 5638
• Device Lot Number: 713903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 59 KG