MAUDE Adverse Event Report: COOK INC COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; OQY INTRAUTERINE BALLOON

Model Number G24237

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

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, in the treatment of pph (post partum hemorrhage) using a cook bakri postpartum balloon with rapid instillation components, the "device was cut".The physician attempted to inflate the "ball" (balloon) but did not succeed.He removed it from the uterus and discovered it to be cut.Additional patient and event information has been requested.A follow up report will be submitted when additional information is received.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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 provided: the patient had uterine atony leading to the post partum hemorrhage (pph).The bakri was placed transabdominally immediately after the cesarean section delivery.It was impossible to fill the balloon because they saw the leakage of the balloon while it was being filled.The bakri remained indwelling for a very short period of time since it was impossible to inflate.It is possible that the bakri was handled by or in the proximity of metal tools during it's placement.It is unknown how much blood was lost prior to bakri placement and it is unknown how blood loss was determined.No other interventions were required as a result of this occurrence, the pph stopped.The patient's co-morbidities are unknown, and it is unknown if the patient had any history of full thickness hysterotomy.This was a singleton gestation.

Manufacturer Narrative

H6: ec methods code desc - 5: communication/interviews (4111).Investigation ¿ evaluation.Asl (b)(6) informed cook on 03feb2019 of an incident involving a cook bakri postpartum balloon with rapid instillation components (j-sosr-100500) from production lot 10073070.As reported, the complaint device was placed trans-abdominally immediately after a cesarean section.The operator attempted to inflate the device with saline but could not due to leakage.The bakri was then removed and found to have a long cut in the balloon material parallel to the catheter.No additional interventions were necessary, as the hemorrhage had stopped at this point.Patient blood loss was not estimated and remains unknown.No adverse effects were reported.A document based investigation was performed including a review of complaint history, device history record, the instructions for use, and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.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: transabdominal placement, post-cesarean section "1.Determine uterine volume by direct examination." "2.From above, via access of the cesarean incision, pass the tamponade balloon, inflation port first, through the uterus and cervix." "note: remove and stopcock to aid in placement and reattach prior to filling balloon." "3.Have an assistant pull the shaft of the balloon through the vaginal canal until the deflated balloon base comes into contact with the internal cervical ostium." "4.Close the incision per normal procedure, taking care to avoid puncturing the balloon while suturing." "note: ensure that all product components are intact and the hysterotomy is securely sutured prior to inflating the balloon.If clinically relevant, the abdomen may remain open upon inflation of the balloon to closely monitor uterine distention and confirm the hysterotomy close." "note: if clinically relevant, a b-lynch compression suture may be used in conjunction with the bakri postpartum balloon." how supplied: "upon removal from the package, inspect the product to ensure no damage has occurred." 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 device was not returned for evaluation.A review of relevant documents was conducted.There is no indication that a design related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The investigation found no other complaints related to this production lot number.Cook has concluded that a definitive cause of the damage to the complaint device can not be determined from the available information.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 information has been received since the last report.

• Brand Name: COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9699149
• MDR Text Key: 199728688
• Report Number: 1820334-2020-00330
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)221010(10)10073070
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2022
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 10073070
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1