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

Model Number G30673

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510k # k170622.A follow up report will be submitted should additional relevant information become available.

Event Description

It has been reported that during the placement of a bakri tamponade balloon catheter in a (b)(6) year old female patient with a history of gemellary pregnancy, blood was flowing "from the surface of intraoperative placental detachment." the complaint device was placed and inflated with 450 ml saline approximately thirty (30) minutes post-cesarean.After thirty (30) minutes having the device in place, the physician was not satisfied with the "hemostatic effect," and removed the bakri tamponade balloon.It was observed, after removal, that only 100 ml liquid was extracted.Before placement, the patient had experienced approximately 1200 ml of blood, and it was reported that after placement, the quantity lost was 400 ml.The physician then tested the complaint device, in-vitro, and discovered a pinhole leakage in the balloon material.Reportedly, sponge forceps were used when handling the device.Hemostasis was achieved through other means of treatment; using another manufacturer's balloon device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

Additional information: investigation ¿ evaluation.A review of dimensional verification, complaint history, device history record , instructions for use , manufacturing instructions, quality controls, specifications, and a visual inspection and functional testing were conducted during the investigation.One device was returned for investigation.The returned packaging confirms the reported complaint device lot number.The visual examination confirmed that the catheter was returned in used condition.The functional testing was performed on the device by inflating the balloon with 150ml of tap water.A leak was confirmed in the proximal end of the balloon material.Under magnification, grasper marks were observed on the balloon material.One of the grasper marks punctured the balloon and caused the leak to occur.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.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warns that 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.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 most probable cause for the balloon puncture was that unintended user error contributed to this incident.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.

• 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: 8833479
• MDR Text Key: 153069623
• Report Number: 1820334-2019-01822
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)210726(10)9049847
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2021
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 9049847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 79