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

Model Number G30673

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2020

Event Type  malfunction  

Manufacturer Narrative

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 caesarean section (c-section) a bakri tamponade balloon catheter was used to treat postpartum hemorrhage (pph).Blood loss was approximately 1500 ml.The bakri was placed transabdominally with the hand then the incision was sutured.The balloon was inflated with saline to 200ml and then they heard the balloon burst.The operator was concerned that the endometrium may of been damaged, so he/she re-opened the suture, removed bakri and checked the uterus.No harm was noted.They inspected the bakri and found a rupture 5-6cm long.Hemostasis was finally achieved with another bakri.Blood loss after issue with the device was 80ml.No adverse effect to the patient has been reported.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.H6: ec method code desc 5: communication/interviews (4111).Investigation evaluation.It was reported on 03apr2020 of an incident involving a cook bakri postpartum balloon (j-sos-100500).As reported, following a cesarean section the patient experienced postpartum hemorrhage and blood loss estimated to be 1500 ml.The bakri balloon was placed transabdominally by hand and the incision was sutured.When the complaint device was inflated with 200 ml of saline, the balloon was heard to burst.The sutures were reopened, the device was removed, and the uterus was confirmed to have been unharmed.The removed device was observed to have a rupture 5 - 6 cm long.Hemostasis was achieved using another bakri device.Blood loss was estimated to be 80 ml.No related adverse events were reported.A visual inspection 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, and quality control data.The complainant returned one a bakri postpartum balloon catheter for investigation.Visual examination confirmed the catheter was returned in used condition.A perpendicular split was observed on the balloon.Under magnification the balloon appeared to have been punctured causing it to split on both sides of the puncture.Length of the split area measured 7cm.A review of the device history record (dhr) 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 related complaints from the lot 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: warns 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.Cook has concluded unintended user error contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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 new patient or event information since the last report was submitted.

• 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: 9929878
• MDR Text Key: 199993600
• Report Number: 1820334-2020-00764
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)200810(10)NS8131911
• Combination Product (y/n): N
• PMA/PMN Number: K170622
• 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: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2020
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: NS8131911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Date Manufacturer Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 71