MAUDE Adverse Event Report: COOK INCORPORATED COOK, SILICONE BALLOON HSG CATHETER WITH CLOSED END AND SIDEPORT; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number G17471

Device Problem Failure to Deflate (4060)

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

Event Date 03/25/2022

Event Type  malfunction  

Event Description

Balloon would inflate but would not deflate.(this is all the information we have from this event).

• Brand Name: COOK, SILICONE BALLOON HSG CATHETER WITH CLOSED END AND SIDEPORT
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 14235907
• MDR Text Key: 290274013
• Report Number: 14235907
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G17471
• Device Catalogue Number: J-CHSG-703001
• Device Lot Number: 13602695
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1