MAUDE Adverse Event Report: COOK INC SILHOUETTE TRANSITIONLESS PUSH-PLUS DESIGN STIFFENED CANNULA; MICROPUNCTURE INTRODUCER, CATHETER

Model Number	MPIS-402-10.0-SC-NT-U-SST
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Micro puncture access obtained in right common femoral artery.During sheath exchange and removal of micro puncture sheath, the micro sheath sheared off on the right groin area.Approximately 5 cm of distal portion of micro introducer sheath sheared off in body.Fda safety report id # (b)(4).

• Brand Name: SILHOUETTE TRANSITIONLESS PUSH-PLUS DESIGN STIFFENED CANNULA
• Common Device Name: MICROPUNCTURE INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; bloomington IN 47404
• MDR Report Key: 8944759
• Report Number: MW5089425
• Device Sequence Number: 2472058
• Product Code: DYB
• UDI-Device Identifier: 00827002355507
• UDI-Public: (01)00827002355507(17)220607(10)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/27/2019

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: 06/07/2022
• Device Model Number: MPIS-402-10.0-SC-NT-U-SST
• Device Catalogue Number: G35550
• Device Lot Number: 9796873
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2019
• 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: Hospitalization
• Patient Age: 83 YR