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

Catalog Number	J-CHSG-503001
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 during preoperative testing, a cook silicone balloon hysterosalpingography injection catheter failed to deflate.After several attempts the device was successfully deflated, however, the customer opened a new device to complete the scheduled sonohysterogram 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.This medwatch is associated with medwatch 1820334-2018-00809 as the same issue was observed on a same-lot device used in a different case.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the cook silicone balloon hysterosalpingography injection catheter was not returned.No photograph or imaging was provided for review.Without the complaint device, a physical investigation was not able to be completed.A document based investigation has been performed.A review of complaint history, the device history record, instructions for use, quality control data and specifications was conducted.The device history record was reviewed and noted there were no non-conformance issues related to the reported failure.A review of complaint history revealed there has been two other complaints associated with the complaint device lot number (8449661) from the same facility and for the same issue.There have been no other complaints received.Prior to distribution, all cook silicone balloon hsg catheters are subjected to an inflation test to ensure proper balloon function.A review of the device history record confirmed that this lot met manufacturing requirements prior to shipment.A review of the instructions for use (ifu) noted the following warnings and precautions: warnings: always inflate the balloon with a sterile liquid.Never inflate with air, carbon dioxide, or any other gas.Precautions: do not overinflate.Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture.A definitive cause for this reported issue could not be determined.Measures have been initiated to address this failure mode.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION 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: 7374318
• Report Number: 1820334-2018-00810
• Device Sequence Number: 1220946
• Product Code: HES
• UDI-Device Identifier: 00827002174726
• UDI-Public: (01)00827002174726(17)201215(10)8449661
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K891290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2018

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 Catalogue Number: J-CHSG-503001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1