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

Model Number G17870

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation: manager of diagnostic imaging.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, prior to an xray hysterosalpingogram using a cook silicone balloon hysterosalpingography (hsg) injection catheter, the device would not deflate.The physician tested the device prior to use on the patient by inflating with 1.5ml of air, but it failed to deflate.Another same type hsg device was tested and used to complete the procedure.No adverse effects were reported due to the alleged malfunction.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

H6: ec method code desc - 5: communication/interviews (4111).Investigation ¿ evaluation: iwk health centre informed cook on 17jan2020 of an incident involving a cook silicone balloon hysterosalpingography injection catheters (j-chsg-703000) from production lot 9877203.As reported, the complaint device was tested with air prior to use in a hysterosalpingogram procedure and would then not deflate.The procedure was successfully completed using another new cook hsg catheter.No adverse events were reported.A visual inspection and functional testing of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, specifications, and quality control data.A visual examination confirmed the catheter was returned bowed and in used condition.The original package and label were not returned.Adequate adhesive was visible on the catheter.A functional test was performed by inflating the balloon with tap water.The balloon partially inflated and water leaked from the distal end near the catheter tip.Under magnification, the balloon material was stretched over the end of the catheter.Closer examination revealed the balloon was severed around the entire circumference of the balloon material.The separation occurred approximately 2-3mm from the end of the catheter.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.A review of complaint history records shows two other complaints associated with the complaint device lot.Due to the individual nature of the manufacturing and inspection process for the devices in the lots, it is unlikely that these events are an indication of device issue within the entire lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: 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." how supplied: "upon removal from the package, inspect the product to ensure no damage has occurred." 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.Cook has concluded unintended user error contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 9631381
• MDR Text Key: 177368825
• Report Number: 1820334-2020-00208
• Device Sequence Number: 1
• Product Code: HES
• UDI-Device Identifier: 00827002178700
• UDI-Public: (01)00827002178700(17)220712(10)9877203
• 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: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2022
• Device Model Number: G17870
• Device Catalogue Number: J-CHSG-703000
• Device Lot Number: 9877203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Date Manufacturer Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1