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

Model Number	7256V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One-unit model 7256 mi kit sheath was returned for evaluation.A manufacturing record review was completed and no related nonconformances were found.A returned product evaluation was completed.The mi kit sheath was returned along with the snare used to remove the shaft from the patient.The hub was separated from the shaft of the sheath.The shaft of the sheath was stuck inside the snare.The returned product showed evidence of sheath movement off the core pin during hub molding.An internal corrective action has been initiated.
Event or Problem Description
While gaining access in the right femoral vein, after the dilator and wire were removed, the hub of the introducer separated from the body of the introducer.The body of the introducer had to be removed from the patient with a snare.Additional information received 01oct19: this was a left heart cath.Access was gained through the right femoral artery.

• 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: 9235292
• Report Number: 2134812-2019-00071
• Device Sequence Number: 19480028
• Product Code: DYB
• UDI-Device Identifier: 10841156102852
• UDI-Public: (01)10841156102852
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2019

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: 05/31/2022
• Device Model Number: 7256V
• Device Catalogue Number: 7256V
• Device Lot Number: 652619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/24/2019
• 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
• Patient Age: 79 YR
• Patient Weight: 78