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

Model Number G30673

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2020

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 that following a delivery of unknown fashion, a bakri tamponade balloon catheter was placed to treat a postpartum hemorrhage but the balloon ruptured during inflation.It is unknown how hemostasis was achieved.No known adverse effects to the patient have been reported.Additional details have been requested regarding the patient and event.At this time no additional information has been provided.A follow up report will be submitted if additional information is received.

Manufacturer Narrative

The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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

Additional information received on 23feb2020: after delivery, the operator immediately discovered a placenta adhesion and dissection (placenta accrete).A bakri was placed transvaginally with sponge forceps and inflated with saline to 100ml when it ruptured.The balloon was indwelling for about 1 minute.The blood loss volume prior to placement was about 400ml and was measured using gauze and a medical bending plate.No transfusions or additional interventions occurred, but hemostasis was achieved by utilizing a balloon from another manufacturer.It was confirmed that there were no adverse effects to the patient.

Manufacturer Narrative

H6: ec method code desc - 5: communication/interviews (4111).Investigation ¿ evaluation: cook was informed on 05feb2020 of an incident involving a cook bakri postpartum balloon (j-sos-100500).As reported, when used to manage postpartum hemorrhage the complaint device ruptured during inflation.No related adverse events were reported.The balloon ruptured during inflation of 100ml of saline.After delivery, the operator found a placenta adhesion and dissection immediately (placenta accreta).A bakri was placed transvaginal immediately with sponge forceps.The balloon was indwelling for about 1 minute.Blood loss before placement was about 400ml, measured by gauze and medical bending plate.No transfusions.No additional interventions.The hemostasis was achieved by using a balloon of another brand.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, specifications, and quality control data.The complainant returned one open packaging tray containing a bakri postpartum balloon catheter for investigation.Visual examination confirmed the catheter was returned in used condition.A functional test was performed on the device by inflating the balloon with tap water.A leak was confirmed near the proximal end of the balloon material.Under magnification, grasper marks were identified on the balloon material.One of the grasper marks punctured the balloon causing it to leak.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: 9719975
• MDR Text Key: 201058619
• Report Number: 1820334-2020-00382
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)220822(10)9965764
• 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,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2022
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 9965764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1