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 11/07/2019

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, following a cesarean section, a bakri tamponade balloon catheter was placed transabdominally and leakage was noted.Water leakage was noted approximately 15cm from the inflation port of the catheter.A kocher clamp was used to clamp the distal side (patient side) of the catheter where the water was leaking.The balloon was used for 16 hours with the kocher clamp in place.There was "not much" blood volume lost from the hemorrhage, and the balloon was "used in a preventative manner".The balloon was used "as is" to complete the procedure.The patient did not experience any adverse effects due to the alleged malfunction.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.H6: ec methods code desc - 5: b13 - communication/interviews.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, quality control data, and specifications.One device was returned for investigation.Visual examination confirmed the catheter was returned in used condition and connected to a drainage bag.The catheter was returned with bodily fluid and blood clots inside the catheter.Before continuing the examination, the device was cleaned and flushed with alconox and water.Once clean, a functional test was performed on the device by inflating the balloon with tap water.A half-moon shaped cut was identified in the catheter shaft.The cut was located 13cm from the inflation lumen.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: warning: 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.Precaution: 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 complaint was confirmed based on evaluation of the returned device.Based on the available information, the most likely cause of this event was unintended user error.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 14nov2019.

• 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: 9321974
• MDR Text Key: 194151031
• Report Number: 1820334-2019-02879
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)220722(10)9895653
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2022
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 9895653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1