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

Model Number	5639
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturing review was completed and zero nonconformances were found.The returned product evaluation confirmed the separation of the distal section of catheter.The entire catheter was severely damaged.All the damage was consistent with over torquing against resistance.The turnpike ifu warns; "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." the most likely root cause for this failure is clinician misuse.
Event or Problem Description
Tip broke off in patient.Tip was retrieved.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7268025
• Report Number: 2134812-2018-00008
• Device Sequence Number: 19362207
• Product Code: DQY
• UDI-Device Identifier: M20656390
• UDI-Public: M20656390
• 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
• Report Date (Section B): 01/26/2018

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: Physician
• Device Expiration Date: 11/01/2019
• Device Model Number: 5639
• Device Lot Number: 615347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 02/13/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention