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

Model Number	5638
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	07/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event description states that the distal tip separated and was left in the patient's coronary.A manufacturing record review was completed and zero nonconformances were found.The returned product evaluation confirmed that a small piece of this distal tip was missing and not returned to vsi with the turnpike catheter.The distal tip section and catheter shaft showed signs of damage consistent with rotating against resistance.The tip was twisted and the ptfe liner was exposed.The most likely root cause for this failure is damage during use.
Event or Problem Description
Patient underwent pci of mid -lad, where a haemodynamically significant stenosis was found (ffr below 0,75).Only one 2.0 mm balloon was dilated, but after this no other balloon could cross the lesion.In order to change to rotawire a turnpike lp was attempted to get through the lesion.No excessive torqueing was used, but the tip got stuck to the lesion and a very small part of it came off.With turnpike gold the lesion was crossed and dilated afterwards.The tip kept on embolizing further and despite different approaches could not be retrieved but embolized to a very small and distal branch without obvious loss worsening of blood flow.Patient was very symptomatic afterwards, but no ecg changes were present.However, tnt rose from immediate 30 ng/l to 480 nm/l, despite which patient insisted on being discharged.Eventually, patient underwent approximately two weeks later pci of lcx due to continuing symptoms.Even this has not resolved patients symptoms.Patient outcome resolved with possible sequelae (nstemi evident) - patient is symptomatic, but it is difficult to determine the causality between the event and symptoms due to their vague nature.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6831444
• Report Number: 2134812-2017-00069
• Device Sequence Number: 60349
• Product Code: DQY
• UDI-Device Identifier: M20656380
• UDI-Public: M20656380
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K142065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2017

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: 04/11/2019
• Device Model Number: 5638
• Device Lot Number: 606535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 08/30/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 100