MAUDE Adverse Event Report: COOK INC BAKRI TAMPONADE BALLOON CATHETER; OQY INTRAUTERINE BALLOON

Catalog Number J-SOS-100500

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510k # k170622.(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 on (b)(6) 2018, the bakri tamponade balloon catheter was used during a lower segment caesarean section (lscs) and the balloon inflated with 300 ml normal saline.The balloon was taken out the next day.Patient presented on (b)(6) 2018 with a plastic piece she had passed from vagina.Additional information was provided on 12sep2018.The device was used prophylactically since patient had placenta praevia.After delivery of the placenta the catheter was passed into the vagina through the incision.They were unaware the catheter had detachable parts and did not check whether it was "complete".An assistant grabbed the end in the vagina and proceeded to fill the balloon."she remembers difficulty due to fluid flowing back.She remembers using the stopcock of a venflon iv catheter to block the end, but none of us actually understood that a piece was missing, perhaps because once the catheter was in, procedure of filling was taken over by a different team of people".The balloon was removed the next day, patient made an uneventful recovery and went home.The patient returned (b)(6) 2018 with a plastic piece she had passed from the vagina.The facility identified the plastic piece as the end of the catheter after comparing it to an unused pack.As per the instructions for use (ifu) that accompanies this device: transabdominal placement, post-cesarean section: note: remove the stop cock to aid in placement and reattach prior to filling balloon.No adverse effects to the patient have been reported as a result of the reported occurrence.

Event Description

There has been no new information received since the last report was submitted.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.The complaint device was not returned for an evaluation.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of the instructions for use, quality control data, and trends.A review of the device history record was unable to be performed as the complaint device lot number was not provided.A review of complaint history for the complaint device lot number could not be performed without the lot number.The instructions for use (ifu) provides the proper warnings, precautions, and instructions for use.According to the transabdominal placement, post-cesarean section: 2.From above, via access of the cesarean incision, pass the tamponade balloon, inflation port first, through the uterus and cervix.Note: remove the stopcock to aid in placement and reattach prior to filling the balloon.The complaint device was not returned.Based on the report from the facility, the cause of the event is the site being unaware of the stopcock being intentionally detachable.The instructions for use indicates the stopcock should be removed when placing the device transabdominally.The investigation conclusion is cause traced to user; failure to follow instructions.A quality engineer risk assessment concluded no risk reduction activities are required.The appropriate internal personnel have been notified and we will continue to monitor 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: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7880622
• MDR Text Key: 120534052
• Report Number: 1820334-2018-02620
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• 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: 11/14/2018

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 Catalogue Number: J-SOS-100500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/17/2018
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 11/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASKU
• Patient Age: 29 YR