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 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 treatment of post-partum hemorrhage 20 hours after a cesarean section, a bakri tamponade balloon catheter leaked near the bottom of balloon upon injecting 60ml of saline.The operator immediately replaced the device with another bakri, inflated with 300ml saline and hemostasis was achieved.Blood loss prior to bakri placement was 2100 ml.Blood loss after bakri placement was 40ml.No additional consequences to the patient have been reported.

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

Corrected information: d 10 (device available for evaluation).Additional information: d10 (device return date).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, the device history record, quality control data, and instructions for use (ifu).The complainant returned one bakri postpartum balloon catheter for investigation.Reported lot number confirmed.Visual examination confirmed the catheter was returned in used condition.A functional test was performed on the open 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 causing it to leak.A device history record (dhr) review for this lot shows no related non-conformances.A review of complaint history revealed no other complaints associated with the complaint device lot number.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: precautions "avoid excessive force when inserting the balloon into the uterus." how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." the complaint was confirmed based on customer testimony and evaluation of the returned device.Based on the available information, the most likely cause of the event was determined to be unintended use error.Per the quality engineering risk assessment, no further action is warranted.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: 8764249
• MDR Text Key: 150136043
• Report Number: 1820334-2019-01622
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)211001(10)9201053
• 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: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 9201053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Date Manufacturer Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPONGE FORCEPS, VAGINAL SPECULUM; SPONGE FORCEPS, VAGINAL SPECULUM
• Patient Age: 39 YR