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

Model Number	5640
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	11/17/2020
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
As reported: a small perforation was noted on a post-procedure echo that was not noted during the successful procedure of a cto-pci of a proximal, non-tortuous, moderately calcific cto in the rca on study subject 010-015.Many devices, both study and non-study devices were used.It is unknown what device used during the procedure, which included study devices of a turnpike spiral microcatheter and a spectre guidewire, caused the perforation.The subject did not become hemodynamically unstable and it was felt that the perforation occurred during retrograde attempt to cross the lesion.Subsequent echos done post-procedure and prior to discharge showed small pericardial effusion adjacent to rv free wall with no evidence of tamponade.Subject discharged next day, resolved without sequelae.Associated mdr: mdr 2134812-2021-00035 spectre guidewire.
Additional Manufacturer Narrative
No product was returned for evaluation.A manufacturing record review was completed and no related non-conformances were found.Patient underwent a cto-pci procedure.The vessel was rca with moderate calcification and no tortuosity.A turnpike (study device) was one of the devices used in the procedure.A small perforation was noted post procedure echo.Per ifu it identifies vessel perforation as potential adverse effects that may be associated with the use of the turnpike catheters.It is unknown if any damages were present in the turnpike that could have caused the perforation.Multiple ancillary devices were used in the procedure.It is unknown which device contributed to the perforation.The subject did not become hemodynamically unstable and it was felt that the perforation occurred during retrograde attempt to cross the lesion.Subsequent echos done post-procedure and prior to discharge showed small pericardial effusion adjacent to rv free wall with no evidence of tamponade.Patient discharged without any sequelae.No adverse events at 30-day follow up.Based on the information, the most likely root cause of the issue is undeterminable.

• Brand Name: TRUNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 11667961
• Report Number: 2134812-2021-00036
• Device Sequence Number: 19567192
• Product Code: DQY
• UDI-Device Identifier: 10841156105082
• UDI-Public: (01)10841156105082
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/25/2021

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 Expiration Date: 05/22/2022
• Device Model Number: 5640
• Device Catalogue Number: 5640
• Device Lot Number: 673775
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 07/27/2021
• 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: Hospitalization
• Patient Age: 59 YR
• Patient Weight: 55