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

Model Number	7242V
Medical Device Problem Codes	Detachment Of Device Component (1104); Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturing record review was completed and zero nonconformances were found.A returned product evaluation was unable to be completed as a product was not sent back to vsi.The final product cause code is therefore undeterminable without any device to perform an evaluation on.
Event or Problem Description
Per medwatch received uf/importer report (b)(4).Interventional cardiologist at initiation of left heart cath used 4f micro-puncture kit cannulated left femoral vein while attempting left femoral access.While ic attempted to remove sheath from the vein, approximately 2 cm of sheath sheared off and remained in patient's left femoral site.Retained sheath could not be visualized with fluoroscopy.Vascular surgeons consulted and determined no vascular intervention needed at this time.Patient with no complaints of pain or discomfort.It is believed retained sheath portion maybe in scar tissue at left femoral site.Additional information received: patient was discharged home - (b)(6) 2018.Pt reported no discomfort at the left femoral site at the time of discharge.Documentation reflects no known harm to patient associated with retention of sheared micropuncture sheath at the time of discharge.The practitioner reported that the sheath sheared off as he was removing sheath from left femoral site.Documentation reflects that the practitioner consulted w vascular surgeons and other interventional cardiologists and no specific therapy was indicated at the time regarding the loss of the sheath tip and pt would be monitored.The only device used at the specific time when this event occurred was the micro-introducer kit.The report was completed by the reporting facility representative within days after the event but was inadvertently filed and not mailed to vendor.Upon discovery of this oversight by the reporting facility representative the medwatch form was sent immediately to the vendor with the date of the report noted to reflect the date it was sent to vendor.

• Brand Name: MICRO-INTRODUCER KIT
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7614227
• Report Number: 2134812-2018-00039
• Device Sequence Number: 2194675
• Product Code: DYB
• UDI-Device Identifier: M2067242V0
• UDI-Public: M2067242V0
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/22/2018

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: Physician
• Device Expiration Date: 02/02/2021
• Device Model Number: 7242V
• Device Lot Number: 620054
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/19/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Weight: 101