MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TURNPIKE SPIRAL 135CM; CATHETER, PERCUTANEOUS

Catalog Number	5640
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: operator was working on a highly calcified lesion.Multiple attempts were made to revascularize the anatomy.Multiple products, methods and access point were all unsuccessful.A spiral was attempted and while the operator was working with that device, the tip separated.According to the nurse lab manager, the physicians report indicates "the micro catheter did break, and it (the tip) was decided to be intentionally left behind.This was a very small piece (approximately 5mm), left in an occluded calcified artery." additional information: the operator mentioned rotating both clockwise and counterclockwise (to offset any torque build up.No stents were placed during the procedure.There was no reported patient harm from the incident.They are dur to return for another attempt at angioplasty.
Additional Manufacturer Narrative
(b)(4).Complaint verification could not be performed as no product was returned for this investigation.The dhr was review and zero non-conformances were found.Line clearance was performed, and all processes were followed correctly.The ifu along with the product states the following warning and precaution never advance, withdraw, or rotate an intravascular device against resistance until the cause of the resistance is determined by f luoroscopy.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 based on the information received it is possible that the turnpike was over torqued during use, and this may have led to the tip damage and separation.Without receiving the device in question, the root cause is undeterminable.The der process will continue to monitor for any similar events.
Event or Problem Description
It was reported that: operator was working on a highly calcified lesion.Multiple attempts were made to revascularize the anatomy.Multiple products, methods and access point were all unsuccessful.A spiral was attempted and while the operator was working with that device, the tip separated.According to the nurse lab manager, the physicians report indicates "the micro catheter did break, and it (the tip) was decided to be intentionally left behind.This was a very small piece (approximately 5mm), left in an occluded calcified artery." additional information: the operator mentioned rotating both clockwise and counterclockwise (to offset any torque build up.No stents were placed during the procedure.There was no reported patient harm from the incident.They are dur to return for another attempt at angioplasty.
Additional Manufacturer Narrative
Qn#(b)(4).In section provided the full udi #.Udi related data quality updates only.
Event or Problem Description
It was reported that: operator was working on a highly calcified lesion.Multiple attempts were made to revascularize the anatomy.Multiple products, methods and access point were all unsuccessful.A spiral was attempted and while the operator was working with that device, the tip separated.According to the nurse lab manager, the physicians report indicates "the micro catheter did break, and it (the tip) was decided to be intentionally left behind.This was a very small piece (approximately 5mm), left in an occluded calcified artery." additional information: the operator mentioned rotating both clockwise and counterclockwise (to offset any torque build up.No stents were placed during the procedure.There was no reported patient harm from the incident.They are dur to return for another attempt at angioplasty.

• Brand Name: TURNPIKE SPIRAL 135CM
• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18129173
• Report Number: 2134812-2023-00052
• Device Sequence Number: 7790432
• Product Code: DQY
• UDI-Device Identifier: 10841156108755
• UDI-Public: (01)10841156108755(11)220908(17)240712(10)73G2200453(21)
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2023

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: 07/12/2024
• Device Catalogue Number: 5640
• Device Lot Number: 73G2200453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 10/17/2023; Not provided
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 12/15/2023; 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED; NOT REPORTED
• Patient Age: 78 YR
• Patient Sex: Male