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

Catalog Number J-SOSR-100500

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: healthcare professional: director.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 a dilation & curettage (d&c) procedure using a cook bakri postpartum balloon with rapid instillation components, the tip of the catheter was separating from the balloon.The bakri appeared to be in place when feeling the patient's abdomen and felt this way throughout the night.Around 0247, the day shift nurse reported that the bakri was having some 'watery' blood output.When observed, the blood was somewhat watery, but it was not enough to be alarmed about.The output of blood continued to get more watery.A bedside ultrasound was completed at 0150 to check the position of the bakri.It was sitting partially in the cervix and lower uterine segment.The physician and nurse planned to remove the bakri at this time.The vaginal packing was removed, and no blood was noted on it.The bakri was removed around 0246 on (b)(6) 2020, and it was noted to be completely deflated.They re-inflated the bakri to test for any leaks, and noted the very tip of the catheter and the balloon were separating and leaking.The patient lost 1600 ml of blood in the or, 800 ml of blood in the pacu, and 600 blood in d&c (400 ml before the bakri was placed).The bakri was placed about 2 hours after delivery and inflated to 280 ml with water the balloon was left in dwelling for 18 hours and 21 mins.The patient was given 2 units of blood during d&c and 2 units during post-partum.Hemostasis had been achieved from a combination of uterine curettage, iv pitocin, im hemabate, and the bakri device placement.According to the initial reporter, there have been no adverse effects to the patient due to this occurrence.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

It was reported on 15mar2020 of an incident involving a cook bakri balloon with rapid installation components (j-sosr-100500) from an unknown production lot.As reported, on (b)(6) 2020, the complaint device was used to manage postpartum hemorrhage following a full thickness hysterotomy as part of the cesarean section.The bakri was placed upon a return to the operating room, and not during the cesarean section.The patient lost 1600 ml of blood in the or, 800 ml of blood in the pacu, and 600 blood in d&c (400 ml before the bakri was placed).The bakri was placed about 2 hours after delivery and inflated to 280 ml.The balloon was left in dwelling for 18 hours and 21 mins.The patient was given 2 units of blood during d&c and 2 units during post-partum.Over the course of the night and next day, the output was noted to be getting more and more watery.A bedside ultrasound noted that the complaint device was sitting partly in the cervix and lower uterine segment.The vaginal packing was removed, and no blood was noted on it.The bakri was removed, and was observed to be completely deflated.The complaint device was reinflated and tested for leaks.The very tip of the catheter and the balloon were observed to be separating and leaking.It was determined that hemostasis had been achieved using a combination of uterine curettage, iv pitocin, im hemabate, and the bakri.No related adverse events were reported.Investigation / evaluation: a document-based investigation was performed including a review of manufacturing instructions, instructions for use (ifu) and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed.There is no evidence to suggest the product was not made to specifications.Cook has not received a similar complaint device for evaluation for a similar failure mode in the past.A review of the device history record could not be completed due to lack of lot information from the user facility.A review of the complaint history could not be completed due to lack of information from the user facility.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: warnings: the bakri postpartum balloon is indicated for use in the event of primary postpartum hemorrhage within 24 hours of delivery.The device should not be left indwelling for more than 24 hours.Patient urine output should be monitored while the bakri postpartum balloon is in use.How supplied: the complainant did not return the complaint device to cook for investigation.Because production lot information was not provided, no representative product from the production lot could be evaluated.Cook could not determine a definitive cause of this event.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.

• 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: 9883053
• MDR Text Key: 197804310
• Report Number: 1820334-2020-00689
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR