MAUDE Adverse Event Report: COOK INCORPORATED COOK INC. FUSION QUATTRO EXTRACTION BALLOON; CATHETER, BILIARY, SURGICAL

Model Number G31921

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

Event Date 03/17/2024

Event Type  Injury  

Event Description

Patient had an ercp in or1 for choledocholithiasis.There was a cook inc.Fusion quattro extraction balloon (size: 12/15/18/20mm, 6.6fr, 200cm, lot#: w4736219, ref#: (b)(4), manufacture date: 6/13/23, and expiration date: 6/13/24) that malfunctioned during use.The balloon would not deflate properly to get the balloon out or the patient.After multiple attempts of removing the syringe from the balloon inflation port and withdrawing air multiple times, it finally deflated.No patient harm reported.

• Brand Name: COOK INC. FUSION QUATTRO EXTRACTION BALLOON
• Type of Device: CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): COOK INCORPORATED
• MDR Report Key: 18986534
• MDR Text Key: 338793845
• Report Number: MW5153205
• Device Sequence Number: 1
• Product Code: GCA
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G31921
• Device Lot Number: W4736219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White