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

Catalog Number	5640
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: on (b)(6) 2023 dr performed a complex occlusion procedure on rca(right coronary artery).After crossing the stenosis with guidewire, he decided to insert a turnpike spiral on the proximal lesion.After few attempts there was a partial tip fracture.Additional information: issue resolved: partial tip of microcatheter remained in target lesion and it was pushed to vessel wall using stent crushing; the use of stent in the segment was planned before due to severe stenosis of the rca.The patients clinical status was reported as fine.
Additional Manufacturer Narrative
Qn # (b)(4).
Event or Problem Description
It was reported that: on 14/07/2023 dr performed a complex occlusion procedure on rca(right coronary artery).After crossing the stenosis with guidewire, he decided to insert a turnpike spiral on the proximal lesion.After few attempts there was a partial tip fracture.Additional information: issue resolved: partial tip of microcatheter remained in target lesion and it was pushed to vessel wall using stent crushing; the use of stent in the segment was planned before due to severe stenosis of the rca.The patients clinical status was reported as fine.
Additional Manufacturer Narrative
(b)(4).There was no product returned for this complaint.No returned product evaluation could be completed.There was no product returned for this complaint.No returned product evaluation could be completed.Lot 73d2300895 was provided by the customer however, per dhr records, it was observed to be a nasal tube product and not a turnpike.Clarification was requested.No correct lot number was provided.Therefore, no record review could be complete.Case details were reviewed.Customer stated "dr performed a complex occlusion procedure on rca(right coronary artery).After crossing the stenosis with guidewire, he decided to insert a turnpike spiral on the proximal lesion.After few attempts there was a partial tip fracture." no unit was returned to vsi/teleflex for evaluation.It is unknown to what extent and degree of damages were incurred on the tip or shaft.Additional information was requested.A response was received.The amount of separation of the tip is unknown.Procedure was completed despite the tip separation.No cd or angiograms of the issue were provided or received.The turnpike spiral was able to be removed aside from the detached tip.The tip was tethered against the wall of vessel with a stent which is the same area which was preplanned to have an angioplasty performed due to the severe stenosis of the rca.Patient condition is fine.Per ifu 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 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.Customer stated that product was used per ifu.It is unknown how many rotations were performed and/or if the catheter was torqued with the tip intact in the lesion.Operating against resistance and subjecting it to excessive rotations could lead to tip fatigue and fracture.A manufacturing record review could not be completed as no correct lot number was provided by the customer.Based on the information, the most likely root cause of the issue is undeterminable.Corrected data: wrong lot# reported by account so udi has been removed as it was incorrect.
Additional Manufacturer Narrative
(b)(4).There was no product returned for this complaint.No returned product evaluation could be completed.There was no product returned for this complaint.No returned product evaluation could be completed.Lot 73d2300895 was provided by the customer however, per dhr records, it was observed to be a nasal tube product and not a turnpike.Clarification was requested.No correct lot number was provided.Therefore, no record review could be complete.Case details were reviewed.Customer stated "dr performed a complex occlusion procedure on rca(right coronary artery).After crossing the stenosis with guidewire, he decided to insert a turnpike spiral on the proximal lesion.After few attempts there was a partial tip fracture." no unit was returned to vsi/teleflex for evaluation.It is unknown to what extent and degree of damages were incurred on the tip or shaft.Additional information was requested.A response was received.The amount of separation of the tip is unknown.Procedure was completed despite the tip separation.No cd or angiograms of the issue were provided or received.The turnpike spiral was able to be removed aside from the detached tip.The tip was tethered against the wall of vessel with a stent which is the same area which was preplanned to have an angioplasty performed due to the severe stenosis of the rca.Patient condition is fine.Per ifu 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 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.Customer stated that product was used per ifu.It is unknown how many rotations were performed and/or if the catheter was torqued with the tip intact in the lesion.Operating against resistance and subjecting it to excessive rotations could lead to tip fatigue and fracture.A manufacturing record review could not be completed as no correct lot number was provided by the customer.Based on the information, the most likely root cause of the issue is undeterminable.
Event or Problem Description
It was reported that: on (b)(6) 2023 dr performed a complex occlusion procedure on rca(right coronary artery).After crossing the stenosis with guidewire, he decided to insert a turnpike spiral on the proximal lesion.After few attempts there was a partial tip fracture.Additional information: issue resolved: partial tip of microcatheter remained in target lesion and it was pushed to vessel wall using stent crushing; the use of stent in the segment was planned before due to severe stenosis of the rca.The patients clinical status was reported as fine.

• Brand Name: TURNPIKE
• 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: 17621921
• Report Number: 2134812-2023-00039
• Device Sequence Number: 14973351
• Product Code: DQY
• UDI-Device Identifier: 10841156100704
• UDI-Public: 10841156100704
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2023

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 Catalogue Number: 5640
• Device Lot Number: 73D2300895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 08/01/2023; 08/01/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 09/29/2023; 09/29/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male