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

Model Number	5640
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing record was reviewed, there were no nonconformance related to this lot, therefore, supporting the device met material, assembly and performance specifications.A follow-up report will be issued after the investigation is complete.
Event or Problem Description
As reported: physician stated the tip of the catheter broke off in a patient procedure with a heavily calcified vessel.Tip was left behind stent, it reported that the tip remnant was "excluded" from the reconstructed vessel lumen by placing a stent over it during the stent phase of the procedure.As the tip remnant was positioned within the target lesion, there would have been no additional stent required.Patient was not harmed; patient had calcified lad cto which was successfully treated.It was reported as torquing too much in calcium.
Additional Manufacturer Narrative
A returned product evaluation was completed.The tip of the catheter was damaged and fatigued.A portion of the tip approximately 0.3 cm was sheared off.It is likely that the damage to the tip occurred during use of catheter in the procedure.Per ifu states the following warnings: never advance, withdraw, or rotate an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter or guidewire against resistance may result in separation of the catheter or guidewire tip, other device damage, or vessel injury.Do not rotate the catheter more than two (2) consecutive 360° rotations in either direction if the distal tip is not also rotating and advancing, as it may result in separation of the catheter, damage to the catheter, or vessel injury.It is unknown from the account if the catheter was used against resistance and/or if the user rotated the catheter more than 2 consecutive turns.The account stated that the broken tip was tethered in the target lesion and a stent was placed over the lesion.Based on the information and returned product evaluation, the most likely root cause of the issue is operation context.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 10525004
• Report Number: 2134812-2020-00058
• Device Sequence Number: 3055184
• Product Code: DQY
• UDI-Device Identifier: 20841156105089
• UDI-Public: (01)20841156105089
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2020

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: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 5640
• Device Lot Number: 670785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 11/06/2020
• 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: 69 YR
• Patient Weight: 108