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

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/26/2019

Event Type  Injury  

Event 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
• Type of Device: MICROPUNCTURE INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; bloomington IN 47404
• MDR Report Key: 8944759
• MDR Text Key: 156256316
• Report Number: MW5089425
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002355507
• UDI-Public: (01)00827002355507(17)220607(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 83 YR