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

Model Number	7266V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A returned product evaluation was unable to be completed as no device was returned for investigation.The manufacturing records were reviewed, and no non-conformances are noted.Based on the limited information, the cause of the separation is undeterminable.
Event or Problem Description
Patient was having a cardiac catheterization through the right femoral vein.The vein was accessed using a micro puncture needle.The needle was taken out and micro puncture sheath broke off from the base with sheath still inside the soft tissue and vein with the wire still present.The cardiologist was unable to retrieve the sheath superficially.A general surgeon was called in to perform a right groin exploration to remove the sheath.
Additional Manufacturer Narrative
One micro-introducer sheath was returned on june 4, 2019 for evaluation; a guidewire also returned.The guidewire was visually inspected, and no damage was present.The micro-introducer sheath was separated just distal to the hub.An angled cut was observed at the separation point on the shaft section that was still connected to the hub.The cut angle and direction visually aligned with an external cut.The separation point on the proximal end of the sheath shaft also had a cut present along with stretched material and several other marks.Based on the event description, it is unknown which marks are related to the separation versus which marks relate to the retrieval.The distal tip of the sheath was examined, and no damage was present.The cause of the shaft separation was unable to be determined due to the limited event details leading up to the separation, but the investigation determined it was not related to a manufacturing issue.

• Brand Name: MICRO-INTRODUCER KIT
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8484200
• Report Number: 2134812-2019-00020
• Device Sequence Number: 1922321
• Product Code: DYB
• UDI-Device Identifier: M2067266V0
• UDI-Public: M2067266V0
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 03/12/2019

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: 12/14/2021
• Device Model Number: 7266V
• Device Lot Number: 639120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 06/26/2019
• 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