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

Model Number	5640
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/01/2020
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
This unit was used during a (b)(6) study case on subject (b)(6).No new adverse events reported at the 30-day study closeout visit.During a (b)(6) procedure of the rca, it is reported that the patient suffered a perforation of the rca resulting in a myocardial infarction and right ventricular failure.At the time of the perforation a bandit guidewire (study device) and a raider guidewire (study device) was inserted into the rca via the antegrade approach.A turnpike spiral (study device) was positioned in the septal via the retrograde approach.Post deployment of a des stent the patient became hemodynamically unstable requiring need for compressions, intubation and insertion of a tvp placed in the rv appendage with patient subsequently recovering.Again, patient became hemodynamically unstable with need for cardioversion.Echo at bedside showed stunned lv and rv and effusion from perforation in the rca.Prolonged balloon inflation and deployment of 3 covered stents (4.0 x 26, 5.0 x 26 and 5.0x20 respectively) stabilized the perforation.Patient stabilized and procedure continued without further incidence.A temporary pacemaker was implanted for post-procedure and patient was extubated at the end of the case.It is unknown what device used was the cause of the perforation though the site states that it was not one of the study devices.Associated to mdr 2134812-2021-00009 bandit gw; mdr 2134812-2021-00010 raider gw.
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.The lot was reviewed, there are no- non-conformances related to this lot therefore, supporting the device met material, assembly and performance specifications.The case details were reviewed.Per ifu, myocardial infarction and vessel perforation are identified as potential adverse effects that maybe associated with the use of turnpike catheter.Account stated that it is unknown that the device caused the perforation though it was not one of the study devices.Procedure continued without further incidence.A temporary pacemaker was implanted for post-procedure and patient was extubated at the end of the case.Based on the information, the most likely root cause of the issue is undeterminable.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 11386825
• Report Number: 2134812-2021-00011
• Device Sequence Number: 3865425
• Product Code: DQY
• UDI-Device Identifier: 20841156105089
• UDI-Public: (01)20841156105089
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 5640
• Device Lot Number: 672429
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 90