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 Consequences Or Impact To Patient (2199)

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The area representative reported the customer uses the cook silicone balloon hysterosalpingography injection catheter regularly.The customer has started having issues with the black check valve malfunctioning.As reported, the balloon was inflated with sterile water using a syringe during a hysterosalpingography procedure.The balloon would not deflate after being filled.The doctor thought the problem was the check valve sticking.Another catheter was used to complete the procedure.There was no harm or any adverse effects to the patient as a result of this reported device issue.

Manufacturer Narrative

Investigation ¿ evaluation: a review of complaint history, the device history records, documentation, drawings, manufacturing instructions, quality control data, and specifications was conducted.Three cook silicone balloon hysterosalpingography injection catheters were returned for evaluation.Device #1, this device was returned with the balloon partially inflated.A functional test was performed.This balloon was found to inflate and deflate fine.Device #2, a functional test was performed on the balloon.The balloon was inflated fine; but it was noted that a lot of pressure was needed to depress the plunger to deflate the balloon.Device #3, a functional test was performed and the balloon inflated and deflated without issue.The black plunger had to be depressed completely for complete deflation.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.The device history record was reviewed and a non-conformance issue was identified.All non-conforming product was reworked.A review for additional complaints for this device lot revealed this complaint to be one of two (2) complaints associated with lot number 8139263.Both complaints are from the same customer.Based on the information provided, evaluation of the returned product and the results of our investigation, the likely root cause is due to the user's technique in handling the product.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
• Type of Device: HES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6979026
• MDR Text Key: 91080412
• Report Number: 1820334-2017-03624
• Device Sequence Number: 1
• Product Code: HES
• UDI-Device Identifier: 00827002171473
• UDI-Public: (01)00827002171473(17)200814(10)8139263
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K891290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other