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

Catalog Number J-CHSG-503000

Device Problem Deflation Problem (1149)

Patient Problem No Patient Involvement (2645)

Event Date 01/09/2018

Event Type  malfunction  

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 Description

It was reported that the physician tested the cook silicone balloon hysterosalpingography injection catheter prior to implantation and observed that it does not deflate.The air only escapes once the balloon has been left lying for a long time.To-date, three units have been affected.Associated with (b)(4) (mdr # 1820334-2018-00096) and (b)(4) (mdr # 1820334-2018-01353).There were no adverse consequences to the patient as a result of this reported issue.The device did not make contact with the patient.

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, manufacturing instructions, 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 7482501.All 3 complaints are from the same facility and for the same issue.There have been no other complaints received.One device from lot 7482501 associated with a different complaint by this customer was previously returned for failure analysis.The evaluation of the device found there was no evidence to suggest a malfunction which would have contributed to this reported failure mode.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 this device is designed for single use only.Attempts to reprocess, resterilize, and/or reuse may lead to device failure and/or transmission of disease.How supplied upon removal from the package, inspect the product to ensure no damage has occurred.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.

Event Description

It was reported that the physician tested the cook silicone balloon hysterosalpingography injection catheter prior to implantation and observed that it does not deflate.The air only escapes once the balloon has been left lying for a long time.To-date, three units have been affected.Associated with (b)(4) (mdr # 1820334-2018-00096) and (b)(4) (mdr # 1820334-2018-01353).There were no adverse consequences to the patient as a result of this reported issue.The device did not make contact with the patient.

• Brand Name: COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
• Type of Device: HES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7500172
• MDR Text Key: 107872164
• Report Number: 1820334-2018-01311
• Device Sequence Number: 1
• Product Code: HES
• UDI-Device Identifier: 00827002171473
• UDI-Public: (01)00827002171473(17)191201(10)7482501
• Combination Product (y/n): N
• PMA/PMN Number: K891290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-CHSG-503000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1