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

Model Number 5640

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Extravasation (1842); Perforation (2001)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing records will be reviewed.A follow-up report will be issued after the investigation is complete.

Event Description

During a cto pci index procedure for the cto-pci study of a severely calcific non-tortuous lesion located in the prox.Lad, the subject suffered an ellis i perforation.Many devices were used during the procedure, both study and non-study and it was felt that perforation was due to catheter course, but it is unknown which device caused the perforation.Study devices used in the procedure included a turnpike spiral microcatheter, spectre 200 cm and 300 cm guidewires, a raider guidewire, and a warrior guidewire.Subject showed no signs or symptoms overtly and possible extravasation was noted on one angiogram.Prolonged balloon inflation was performed in suspected area prophylactically, but not specifically for tamponade or perforation, protamine was administered to reverse anticoagulation.Post-procedure tee showed no effusion.Subject discharged home next day, resolved without further sequelae.No adverse events were reported at study 30-day follow-up visit.Associated mdrs: mdr 2134812-2021-00037 raider gw.Mdr 2134812-2021-00038 spectre guidewire.Mdr 2134812-2021-00039 spectre guidewire.Mdr 2134812-2021-00041 warrior guidewire.

Manufacturer Narrative

There was no product returned for this complaint.No returned product evaluation could be completed.A manufacturing record review was completed and no related non-conformances were found.Patient underwent a cto pci procedure.The vessel was lad with severe calcification and no tortuosity.A turnpike spiral was one of the devices used in the case.The patient endured an ellis i perforation.Per ifu, vessel perforation was identified as a potential adverse effect that may be associated with the use of the turnpike spiral catheter.It is unknown if the turnpike spiral was damaged during use that contributed to the event without product evaluation.Multiple ancillary devices were used in the case.It is unknown which device caused the perforation.Patient did not show any symptoms.Possible extravasation was noted on the angiogram.Prophylactic prolonged balloon inflation treatment was employed in the suspected area.Protamine administered to reverse anticoagulation.Post procedure tee showed no effusion.Patient discharged without any sequelae.No adverse events reported at the 30 days follow up visit.Based on the information, the most likely root cause of the issue is undeterminable.

• Brand Name: TURNPIKE SPIRAL
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 11668320
• MDR Text Key: 245502989
• Report Number: 2134812-2021-00040
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10841156105082
• UDI-Public: (01)10841156105082
• Combination Product (y/n): N
• PMA/PMN Number: K191560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2022
• Device Model Number: 5640
• Device Catalogue Number: 5640
• Device Lot Number: 677513
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 53