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

Model Number	7262V
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.A image was sent by the account that pertains to the sheath.Damages could not be determined from the image, since it did not include the image of the dilator.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
As reported: the access site was calcified.The 4f stiffen micro-introducer failed during access.Specifically, the distal 5cm of the introducer broke off in the patients right femoral artery upon pullback by physician.There was no significant resistance felt during the withdrawal, however, there was a very slight bit of resistance right prior to the introducer coming out of the body.Site reported that this product still has not been released by risk management at site, so it will not be able to be sent immediately.Multiple attempts were made to the site for return of the device for evaluation.

• Brand Name: MICRO-INTRODUCER KIT
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 10395075
• Report Number: 2134812-2020-00045
• Device Sequence Number: 14340817
• Product Code: DYB
• UDI-Device Identifier: 20841156102873
• UDI-Public: (01)20841156102873
• 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): 07/17/2020

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: 10/31/2022
• Device Model Number: 7262V
• Device Lot Number: 661671
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/12/2020
• 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: Other
• Patient Age: 64 YR
• Patient Weight: 92