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

Catalog Number J-CHSG-503001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 03/19/2018

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 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 1820334-2018-00810 as the same issue was observed on a same-lot device used in a different case.

Manufacturer Narrative

Investigation ¿ evaluation: visual examination and functional testing of the returned product was performed.Additionally, a review of complaint history, the device history record, instructions for use, quality control data and specifications was conducted.One device was returned for investigation.A functional test was performed.The balloon inflated properly, no leaks noted.When deflating the balloon, pressure was needed on the plunger, however, the balloon did deflate.The device history record was reviewed and noted there were no non-conformances issues related to the reported failure.A review of complaints revealed one other complaint associated with the complaint device lot number 8449661.The other complaint was received from the same customer.A review of relevant manufacturing documents was conducted.The device is inspected visually and functionally for leaking and inflation during manufacturing and no notable gaps in production or processing controls were noted.The instructions for use (ifu) provides relevant 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.Refer to product label or the inflation check valve on the balloon device for appropriate balloon volume.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.Prior to distribution, all cook silicone balloon hsg catheters are subject to an inflation test to ensure proper balloon function.A review of the device history record confirmed that this lot met manufacturing specification requirements prior to shipment.A definitive cause of the reported issue could not be determined.Measures have been initiated to evaluate 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
• MDR Report Key: 7374230
• MDR Text Key: 103588288
• Report Number: 1820334-2018-00809
• Device Sequence Number: 1
• Product Code: HES
• UDI-Device Identifier: 00827002174726
• UDI-Public: (01)00827002174726(17)201215(10)8449661
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-CHSG-503001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1