MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC PRONTO V4; CATHETER

Model Number	4006
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has returned for evaluation and an investigation has been opened to review device and history records, and risk documentation.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
As reported: patient was undergoing tibial angioplasty and extraction of thrombus.The pronto v4 was placed over a an.014 guidewire and an extraction was performed.The pronto was flushed and placed back over the.014 wire but became jammed on the wire.The operator wasn't able to pass the pronto further into the patient or retrieve it over the wire.The catheter was pulled and split on the wire, leaving a portion stuck on the guidewire.This portion could not be moved and had to be grasped with a surgical mosquito to hold it to remove it from the guidewire.The remaining part of the catheter then came off the guidewire in pieces, and the procedure was continued with a second device.
Additional Manufacturer Narrative
A manufacturing record review was completed and no related nonconformances were found.One unit of pronto was returned to vsi/teleflex for investigation.A returned product evaluation was completed.Catheter was damaged and fragmented.The fragmented pieces were severely damaged and deformed.The damages found on the catheter and segments is likely to have occurred during use with concomitant devices in procedure.Per ifu, states the following warning and precaution: never advance or withdraw 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, damage to the catheter, or vessel perforation.Exercise care in handling of the catheter during a procedure to reduce the possibility of accidental breakage, bending or kinking the account was inquired on procedure details.Few responses were received.It was noted that the device was used per ifu and the patient was not affected by the incident.However, it is unknown if fragments were left inside the patient, any noted concomitant device damages, evidence that the catheter broke inside the patient's vessel, calcification and tortuosity level of the vessel and any resistance felt during use of pronto.Based on the information and returned product evaluation, the most likely root cause of the issue is operational context and/or unintended use error.

• Brand Name: PRONTO V4
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 10574988
• Report Number: 2134812-2020-00061
• Device Sequence Number: 19137050
• Product Code: DXE
• UDI-Device Identifier: 30841156100234
• UDI-Public: (01)30841156100234
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K103405
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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: 10/19/2021
• Device Model Number: 4006
• Device Lot Number: 660444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/23/2020
• 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