MAUDE Adverse Event Report: COOK INC COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; OQY INTRAUTERINE BALLOON

Model Number G24237

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510k #: k170622.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported, after uterus contraction therapy was completed to treat a post-partum hemorrhage, a cook bakri postpartum balloon with rapid instillation components was placed within the patient with sponge forceps.The operator found that after the device was implanted that it could not be inflated.The balloon was then removed and tested, and the hub detached and fell to the floor.Another device was used to complete the procedure.No adverse effects to the patient occurred due to this malfunction.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Ec method code desc - 5: communication/interviews (4111).Ec method code desc - 6: incomplete device returned (4116) additional information: d10 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, and quality control data.One device was returned for investigation.Visual examination confirmed the catheter was returned in used condition.The stopcock was not returned with the catheter.The instillation components were also not returned.There were no physical anomalies observed on the device.A functional test was performed on the open device by inflating the balloon with 150ml of tap water.There was no leak detected in or around the balloon.The balloon functioned as intended.It is noted that the catheter was returned without the stopcock, and without he stopcock water leaks from the inflation line fittings.A stock stopcock fitting was used when inflated and no leaks were detected when closed off properly.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.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.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: the maximum inflation is 500ml.Do not overinflate the balloon.Balloon should be inflated with sterile liquid.Balloon should never be inflated with air, carbon dioxide or any gas.The ifu also precautions to avoid excessive force when inserting the balloon into the uterus.The reported failure could not be replicated using the returned portion of the complaint device.A definitive cause of the reported event could not be determined.The complaint was confirmed based on customer testimony.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.

Event Description

No additional patient or event information has been received since the last report was submitted on 01nov2019.

• Brand Name: COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9267059
• MDR Text Key: 164640138
• Report Number: 1820334-2019-02752
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)210102(10)8481207
• Combination Product (y/n): N
• 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: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2021
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 8481207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 52