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

Model Number	5640
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "tip of the microcatheter (turnpike spiral) detached and stayed entrapped on the guidewire.Needed to remove the guidewire over a guide extension." actual complaint device is available for investigation.Additional information on 08dec2022: during a percutaneous coronary intervention (pci) of a chronic total occlusion (cto) in the left anterior descending artery(lad), there was reported difficulty during use and during removal of the turnpike spiral.After the tip detached the device was removed in its entirety and replaced.The issue was resolved by removal using guide extension.Another attempt was performed and successful.There were no patient complications.The patient was stable post procedure and had no extended hospital stay.
Additional Manufacturer Narrative
(b)(4).An investigation has been opened to review historical data and risk documentation.A follow up investigation will be submitted after investigation.
Additional Manufacturer Narrative
(b)(4).One-unit of turnpike was returned for evaluation.Blood particulates were noted on the catheter.The tip of the catheter was observed to be fatigued exposing a minor portion of the liner.No guidewire returned to confirm tip material separation.The tip was observed to be 10.5 mm.Likely a very small portion of the tip i.E.Approximately 0.5 mm could be missing.The top-level assembly traveler was reviewed.There are no dda's, nce's or any other nonconformances related to this lot therefore supporting the device met material, assembly and performance specifications.Case details were reviewed.A patient underwent a procedure for cto-pci of the lad.Tip of the microcatheter detached and stayed entrapped on the guidewire.One unit of turnpike was returned for evaluation.The tip was observed to be fatigued with a minor exposure of the inner lumen.The tip measured about 10.5 mm.Approximately less than 0.5 mm separation is likely to have occurred.No guidewire was returned to confirm tip entrapment on the guidewire.The damages are likely to have occurred during use when operated against resistance against a calcified vessel.Per ifu the following warnings and precaution were noted; 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.Exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage, bending, or kinking.Additional information was requested.A response was received.The unit was removed in its entirety via the guide extension catheter.Another unit was used to complete the case.No other intervention was done.No other patient complications noted.It likely due to the interaction of the tip against a calcified vessel could have caused it fatigues when rotated or operated against resistance.No significant tip separation noted.Only a very small portion less than 0.5 mm was noted to be missing.No guidewire returned for evaluation of damages.A manufacturing record review was completed and no related nonconformances were found.Based on the information, the most likely root cause of the issue is operational context and/or unintended use error.
Event or Problem Description
It was reported that "tip of the microcatheter (turnpike spiral) detached and stayed entrapped on the guidewire.Needed to remove the guidewire over a guide extension." actual complaint device is available for investigation.Additional information on 08dec2022: during a percutaneous coronary intervention (pci) of a chronic total occlusion (cto) in the left anterior descending artery(lad), there was reported difficulty during use and during removal of the turnpike spiral.After the tip detached the device was removed in its entirety and replaced.The issue was resolved by removal using guide extension.Another attempt was performed and successful.There were no patient complications.The patient was stable post procedure and had no extended hospital stay.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16022158
• Report Number: 2134812-2022-00059
• Device Sequence Number: 6894755
• Product Code: DQY
• UDI-Device Identifier: 10841156105082
• UDI-Public: 10841156105082
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K191560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/11/2024
• Device Model Number: 5640
• Device Catalogue Number: 5640
• Device Lot Number: 717925
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2022
• Supplement Date Received by Manufacturer: 11/25/2022
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 84 KG