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

Model Number	7208V
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One-unit model 7208v was returned for evaluation.A manufacturing record review was completed and no related nonconformances were found.A returned product evaluation was completed.The distal weld was separated, and the outer coil was pulled away from the core wire.Based on the event details the most likely root cause can be attributed to user error.The ifu (42-0734-01) warns; "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.
Event or Problem Description
As reported the patient was in the cardiac cath lab (ccl) for a left heart cath.Per the physicians' dictation, he initially tried accessing the r femoral artery using micro-puncture.There was difficulty advancing the wire, so the physician attempted to remove the wire but experienced difficulty retracting.The access needle was then removed but the wire still wouldn't pull back.The physician then pulled with more force and the tip of the wire was dislodged with some threading of the wire as it was removed and "a very small portion of the wire tip was seen on fluoro, but it appeared extravascular." no further complications were reported.There was no documentation pertaining to the planned removal of the foreign body.

• Brand Name: MICRO-INTRODUCER KIT
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneaplois, mn
• MDR Report Key: 10272979
• Report Number: 2134812-2020-00041
• Device Sequence Number: 811609
• Product Code: DYB
• UDI-Device Identifier: 10841156102685
• UDI-Public: (01)10841156102685
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2022
• Device Model Number: 7208V
• Device Catalogue Number: 7208V
• Device Lot Number: 663268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 98