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

Model Number G30673

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

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, during the treatment of post partum hemorrhage (pph) following a c-section using a bakri tamponade balloon catheter, the balloon was leaking.The operator initially used gauze packing following the uterine treatment, but the situation did not improve.The patient was sent to the icu, and the blood loss following the delivery was about 2500ml.The operator removed the gauze, sutured the bleeding site, and place the bakri device by hand through the incision.The operator began to inflate the balloon after the incision was sutured, but liquid was flowing out during the inflation process.The operator removed the device and replaced with a new bakri, and hemostasis was successfully achieved.The blood loss after the replacement was about 100ml.No adverse effects have been reported due to the alleged malfunction.

Manufacturer Narrative

H6: ec method code desc: trend analysis (4110).Investigation evaluation: a document based investigation was performed including a review of complaint history, device history record, the instructions for use, and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.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 lot related complaints that 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: instructions "transabdominal placement, post-cesarean section" "1.Determine uterine volume by direct examination." "2.From above, via access of the cesarean incision, pass the tamponade balloon, inflation port first, through the uterus and cervix." "note: remove and stopcock to aid in placement and reattach prior to filling balloon." "3.Have an assistant pull the shaft of the balloon through the vaginal canal until the deflated balloon base comes into contact with the internal cervical ostium." "4.Close the incision per normal procedure, taking care to avoid puncturing the balloon while suturing." 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.The device was not returned for evaluation.A review of relevant documents was conducted.There is no indication that a design related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The investigation found there were no other complaints related to this production lot number.A definitive cause of the complaint could not be concluded.Per the quality engineering risk assessment, no further action is warranted.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

No additional patient or event information has been received since the last report was submitted on 06dec2019.

• 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: 9424324
• MDR Text Key: 195043407
• Report Number: 1820334-2019-03022
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)200123(10)7614096
• 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: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2020
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 7614096
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 68