MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC MICRO-INTRODUCER KIT; CATHETER

Model Number	7246V
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing record was reviewed, there were no nonconformance related to this lot, therefore, supporting the device met material, assembly and performance specifications.A follow-up report will be issued after the investigation is complete.
Event or Problem Description
It was reported that during the insertion a part of the micropuncture sheath sheared off, which was discovered after removal.Scanning the chest with fluoroscopy with physician there is an artifact in the right midlung which may have represented this, but it appears to be not fully in the pulmonary artery.After discussion it was felt that attempts at removing this would result in more harm than good.No adverse hemodynamic events noted.No further complications were reported.Medwatch (b)(4) received from site 06aug2020.
Additional Manufacturer Narrative
A returned product evaluation was completed.The sheath was damaged, and part of the lumen was sheared off (i.E approximately 5.5 cm).The distal lumen (i.E damaged section) appears to be stretched and pulled against resistance during use in procedure.Per ifu it states the following warning which is " never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the guidewire against resistance may result in separation of the guidewire tip, damage to the guidewire, or vessel perforation".The account responded to procedure details stating that no resistance was felt during insertion, no needle interaction noted, and no presence of calcium or tortuosity in the vessel.Also, no plan is made to remove the fragment from the anatomy as it may be detrimental for the patient.It is undeterminable if the mik was used per the ifu.Based on the information and returned product evaluation, the most likely root cause of the issue is undeterminable.

• Brand Name: MICRO-INTRODUCER KIT
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 10474845
• Report Number: 2134812-2020-00056
• Device Sequence Number: 16726227
• Product Code: DYB
• UDI-Device Identifier: 20841156103146
• UDI-Public: (01)20841156103146
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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: 09/30/2022
• Device Model Number: 7246V
• Device Lot Number: 661369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 11/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Weight: 88