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

Lot Number 8396657

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2020

Event Type  Injury  

Event 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
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK, INC. ; bloomington IN 47402 489
• MDR Report Key: 10657692
• MDR Text Key: 211031123
• Report Number: MW5097165
• Device Sequence Number: 1
• Product Code: PNC
• UDI-Device Identifier: 00827002132641
• UDI-Public: 0827002132641
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2020
• Device Lot Number: 8396657
• 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): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 64