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 Codes	Embolism (1829); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A returned product evaluation confirmed that the turnpike lp was severely damaged and the single coil over braided section was exposed through the outer polymer layer.The tungsten distal tip of the catheter had a small piece missing that was not returned with the catheter.The additional information provided states there was nothing left inside the patient.The damage found is consistent with over torqueing the catheter against resistance.The most likely root cause for the failure is damage during use.
Event or Problem Description
During a retrograde procedure, the tip of micro catheter was kinked, the junction between tapered and non-tapered part got "decoiled'.It was impossible to retrieve the wire.The physician has assumed that the junction between tapered and not tapered microcatheter shaft was decoiled because he was not able to pull back only the guidewire.During surgical intervention, the operator was able to pull back the micro-catheter and wire together, without injury to septal collaterals.The procedure was concluded with success.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7159977
• Report Number: 2134812-2018-00001
• Device Sequence Number: 10787238
• Product Code: DQY
• UDI-Device Identifier: M20656390
• UDI-Public: M20656390
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2017

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: 05/15/2019
• Device Model Number: 5639
• Device Lot Number: 607758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 01/03/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 100