MAUDE Adverse Event Report: COOK INC INTRAUTERINE ACCESS BALLOON CATHETER; HES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES)

Catalog Number	J-IAB-090023
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	05/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that the intrauterine access balloon catheter would not deflate.Another new balloon was used to complete the procedure successfully.There were no adverse consequences to the patient as a result of this reported issue.The device did not make contact with the patient.
Additional Manufacturer Narrative
Investigation ¿ evaluation: an intrauterine access balloon catheter was returned for investigation.The device was returned with the balloon deflated.A functional test was performed and the balloon was found to inflate without incident.Upon deflating the balloon, it was found that pressure was needed when inserting the syringe against the black plunger.History has shown this is normal with this inflation valve.The device history record was reviewed, there were no non-conformances that were related to the alleged failure.A review of complaint history revealed this complaint is the only one associated with lot number 7986424.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.It was determined that the balloon functioned as intended.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
Event or Problem Description
No additional information received regarding the event.

• Brand Name: INTRAUTERINE ACCESS BALLOON CATHETER
• Common Device Name: HES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7554215
• Report Number: 1820334-2018-01585
• Device Sequence Number: 19151850
• Product Code: HES
• UDI-Device Identifier: 00827002303973
• UDI-Public: (01)00827002303973(17)200613(10)7986424
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K890869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2020
• Device Catalogue Number: J-IAB-090023
• Device Lot Number: 7986424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1