MAUDE Adverse Event Report: COOK, INC. FLEXOR, TUOHY-BORST SIDE-ARM INTRODUCER; INTRODUCER, CATHETER

Model Number KSAW-6.0-38-90-RB-SHLT-FLEX-HC

Device Problem Kinked (1339)

Patient Problem No Information (3190)

Event Date 07/27/2017

Event Type  Injury  

Event Description

Kink (small dimple) in the sheath noted in introducer.After advancing the sheath into the artery and over the bifurcation, an attempt was made to insert a wire and catheter through the sheath.Attempt was unsuccessful.Kink noted right at the bifurcation approximately where the deformity was noted.

• Brand Name: FLEXOR, TUOHY-BORST SIDE-ARM INTRODUCER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• MDR Report Key: 6785024
• MDR Text Key: 82486898
• Report Number: MW5071474
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2020
• Device Model Number: KSAW-6.0-38-90-RB-SHLT-FLEX-HC
• Device Catalogue Number: G31138
• Device Lot Number: 7843551
• 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: 66 YR
• Patient Weight: 120