MAUDE Adverse Event Report: COOK INC COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER; OQY INTRAUTERINE BALLOON

Model Number G17147

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2020

Event Type  malfunction  

Manufacturer Narrative

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 a uterine angiography using a cook silicone balloon hysterosalpingography injection catheter, the operator placed the device and began to inflate but no change was observed.The device was removed, and the balloon was found to be broken.On 02jun2020, additional information was received that the balloon had ruptured.The procedure was completed by using another new device.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

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event description: it was reported on (b)(6) 2020 of an incident involving a cook silicone balloon hysterosalpingography injection catheter (j-chsg-503000).As reported, the complaint balloon would not fill properly during use.Another device was used to successfully complete the procedure.No adverse evets were reported.Investigation ¿ evaluation 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, specification, and quality control data.The complainant returned one cook silicone balloon hysterosalpingography injection catheter for investigation.Visual examination confirmed the catheter was returned in used condition.Catheter length measured 30cm from distal tip to the hub.The catheter is kinked in three locations, 7.7cm, 21.3cm, and 30cm from distal tip.A functional test was performed by flushing tap water through the catheter; balloon would not inflate.The balloon was intact and not ruptured.No leakage around the inflation valve.Water leaked from the fitting on the opposing extension tube indication lumen communication a review of the device history record (dhr) found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: 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.How supplied: "upon removal from the package, inspect the product to ensure no damage has occurred." cause of event is unknown.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: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10184923
• MDR Text Key: 196417328
• Report Number: 1820334-2020-01170
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 00827002171473
• UDI-Public: (01)00827002171473(17)220213(10)9518268
• Combination Product (y/n): N
• PMA/PMN Number: K891290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2022
• Device Model Number: G17147
• Device Catalogue Number: J-CHSG-503000
• Device Lot Number: 9518268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/23/2020
• Supplement Dates Manufacturer Received: 07/09/2020
• Supplement Dates FDA Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 55