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

Model Number	5642
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: complete tip separation.When the turnpike smooth was advanced, and the physician started advancing in a clockwise motion the entire tip immediately separated with very little resistance.He said it didn't feel right, and upon removal for inspection the tip was already separated and detached.The tip was left in, and another guidewire was unable to cross.The tip was not able to be retrieved.Additional information on 05aug2022: the entire tip of the turnpike smooth came off and it was not retrievable and remains in the vessel.It was reported that there was a clear channel and the physician experienced little resistance advancing the catheter.An angiogram was submitted for investigation.Patient's current condition is reported as fine.
Additional Manufacturer Narrative
Manufacturing records will be reviewed.A follow-up report will be issued after the investigation is complete.
Additional Manufacturer Narrative
One-unit of turnpike was for evaluation.Blood particulates were noted on the unit.Tip separation was confirmed.Approximately 6-7 mm of tip was missing.Tip material was observed to be fatigued.A manufacturing record review was completed and no related nonconformances were found.Case details were reviewed.Patient underwent a pci procedure.A turnpike was used in the case.Turnpike was advanced with catheter rotated in clockwise motion.The tip separated with little resistance.One-unit of turnpike was returned for evaluation.Blood particulates were noted on the unit.Tip separation was confirmed.Approximately 6-7 mm of tip was missing.Tip material was observed to be fatigued.The damages are likely to have occurred during use when operated against resistance against a lesion.Per ifu states the following warnings and precaution: - 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 tip was stuck in the lesion and was unable to be retrieved.The tip could not be stented against the vessel wall as it was unable to be crossed.A fluoroscopic image was shared by the account.A turnpike along with a guidewire could be noted on the vessel.Account stated that picture depicted the tip broke off, however it appears that the turnpike was still intact on the shaft.Product return showed part of the tip intact with the shaft that does not correlate with the fluoroscopic image.The angiogram image cannot be confirmed of the tip separation issue.It is likely that the distal section of the tip could have interacted with lesion when it was stuck, causing it to wear off during advancement.Subsequently, leading it to break off.Evidence of fatigued tip material could be noted at the break away junction.Procedure was aborted.Patient condition is fine based on the information, the most likely root cause of the issue operational context and/or unintended use error.

• Brand Name: TURNPIKE SMOTTH
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: angela meister ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564253
• MDR Report Key: 15254499
• Report Number: 2134812-2022-00051
• Device Sequence Number: 12233923
• Product Code: DQY
• UDI-Device Identifier: 10841156108779
• UDI-Public: 10841156108779
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K212211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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: 09/11/2023
• Device Model Number: 5642
• Device Catalogue Number: 5642
• Device Lot Number: 73L2100492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 89 YR
• Patient Sex: Female