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

Model Number	7206V
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no product returned for this complaint as yet.No returned product evaluation could be completed.An image was sent by the account that pertains to the sheath and hub separation.Manufacturing record review was completed and no related nonconformances were found.If the device returns for evaluation a follow-up report will be submitted.At this time cause could not be established.
Event or Problem Description
After gaining access to the left common femoral artery with a 5f micro introducer, a guidewire was inserted but was unable to advance past an iliac stenosis.When the guidewire was removed, the hub of the sheath came off and the shaft remained inside the patient.The physician was able to successfully snare the shaft from the contra-lateral side and remove it from the patient in its entirety.The patient is doing fine with no issues.
Additional Manufacturer Narrative
One unit of mik was returned to vsi/teleflex for investigation.A returned product evaluation was completed.Hub of the device separated from the shaft.The tip of the sheath was noted to be anomalous.The failures noted on the unit is likely to be a manufacturing/process deficiency.Internal corrective actions were initiated to address this issue.

• Brand Name: MICRO-INTRODUCER KIT
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 10451547
• Report Number: 2134812-2020-00050
• Device Sequence Number: 14342287
• Product Code: DYB
• UDI-Device Identifier: 20841156103122
• UDI-Public: (01)20841156103122
• 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): 07/30/2020

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: 05/05/2023
• Device Model Number: 7206V
• Device Lot Number: 672781
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 11/05/2020
• 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
• Patient Age: 53 YR
• Patient Weight: 64