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

Catalog Number J-SOS-100500

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation: non-healthcare professional.(b)(4).Pma/510k #: k170622.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, a patient with natural labor experienced puerperal hemorrhage.As reported, the amount of bleeding reached 200 milliliters (ml) before the bakri tamponade balloon catheter was placed to stop the bleeding.As reported, the physician held the balloon by hand and placed it into the uterine cavity through the vagina, then the physician injected the balloon but leaking was found at the three-way valve.The balloon was removed and another new, same type of device, was used to stop the bleeding successfully.No adverse events have been reported as a result of the alleged malfunction.

Event Description

There has been no new event information received since the last report was submitted on 09aug2018.

Manufacturer Narrative

Conclusion codes: cause not established (4315).Investigation/evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed.This included a review of complaint history, the device history record, drawings, quality control data, and specifications.One device was returned for investigation.A visual examination noted the inflation line is split in the seam.A review of the device history record was performed and noted there were no non-conformances that would cause or contribute to the failure mode.A search of complaint records revealed this is the only complaint associated with lot: 8433282.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Based on the provided information, device analysis, and records review, no conclusion could be made as to the cause of this failure mode.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and 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.

Event Description

Additional information was received on 31jul2018.It was reported, the cause of the puerperal hemorrhage was rupture of the lower uterine segment.The total blood loss before hemostasis was achieved was 450 milliliters (ml).The patient was reported to be in good condition.Additional information was received on 09aug2018.It was reported, mother had a full-term, normal vaginal delivery.

• 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: 7727146
• MDR Text Key: 115407529
• Report Number: 1820334-2018-02177
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)201211(10)8433282
• 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,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2020
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 8433282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Date Manufacturer Received: 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 69