MAUDE Adverse Event Report: COOK INC. CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number G17147

Device Problems Air Leak (1008); Inflation Problem (1310); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/06/2018

Event Type  malfunction  

Event Description

Procedure was for hsg.Catheter inserted into patient's cervix by md, 1 ml balloon was inflated, but the balloon would not stay inflated resulting in air being present for exam.Radiologist suggested patient come back for repeat exam.Cook medical supply was called to report the catheter balloon was defective.

• Brand Name: CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COOK INC.; bloomington IN 47404
• MDR Report Key: 7464486
• MDR Text Key: 106791427
• Report Number: MW5076781
• Device Sequence Number: 0
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2021
• Device Model Number: G17147
• Device Lot Number: 8576018
• Was Device Available for Evaluation?: No
• 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 Age: 31 YR