MAUDE Adverse Event Report: COOK, INC. 6F 90CM SHUTTLE SHEATH; INTRODUCER, CATHETER

Lot Number	8396657
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Fracture and separation of the left radial artery sheath upon sheath removal.Patient was transferred to the operating room for surgical removal.Fda safety report id# (b)(4).

• Brand Name: 6F 90CM SHUTTLE SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK, INC. ; bloomington IN 47402 489
• MDR Report Key: 10657692
• Report Number: MW5097165
• Device Sequence Number: 3093936
• Product Code: PNC
• UDI-Device Identifier: 00827002132641
• UDI-Public: 0827002132641
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/27/2020
• Device Lot Number: 8396657
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2020
• 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: 78 YR
• Patient Weight: 64