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

Model Number G24237

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation: other non-healthcare professional: compliance and customer service coordinator.Pma/510k #: k170622.A follow up report will be submitted should additional relevant information become available.

Event Description

It is reported during an unspecified procedure using a cook bakri postpartum balloon with rapid instillation components, "at the time of withdrawal of the ball it was not evident that liquid was used to initially inflate" (thought to mean no fluid present in the balloon).It is unknown how the procedure was completed.It was reported that this incident did not generate any harm to the patient.Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.

Event Description

No additional patient or event information has been provided since the last report sent.

Manufacturer Narrative

Ec method code desc - 5: communication/interviews (4111).Investigation ¿ evaluation.A visual inspection could not be performed as the device was not returned.A document based investigation was performed including a review of complaint history, the device history record, instructions for use, and quality control data.A review of the device history record revealed no non-conformances related to the reported failure.A review of complaint records revealed no other complaints associated with the reported 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.Cook also reviewed product labeling.The product ifu provides the following information to the user related to the reported failure mode: how supplied: upon removal from the package, inspect the product to ensure no damage has occurred.Cook has reviewed the device master record (dmr) review for this product and has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Device failure analysis: the complainant did not return the complaint device to cook for investigation.Cook has received a complaint for a similar j-sos-100500 product experiencing a similar unintended deflation failure mode.The physical examination of the complaint device for that complaint found that the returned device had fluid in the balloon and when the stopcock was moved to the open position, water flowed out of the balloon.Using a syringe, fluid could be drawn through the stopcock.500 ml of water was then injected into the balloon and withdrawn from the balloon without any issue.The investigation for this case concluded that the customer's difficulty could not be replicated in the laboratory and that a definitive cause of the complaint could not be determined.Because of the similarities between the referenced complaint and the current complaint, it is possible that physical evaluation of this complaint device would also fail to yield a definitive conclusion.Conclusion: definitive cause of the reported event could not be determined.The risk analysis for this failure mode was reviewed and additional escalation was not recommended.The complaint was confirmed based on customer testimony.Cook 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.

Event Description

Additional information received 30jan2020: the procedure was a balloon installation to stop post partum hemorrhage.The balloon was filled to 500c with saline.The nature of the hemorrhage was uterine atony.The patient was transferred to an intensive care unit, after a 5 hours indwelling, the saline solution that was used to inflate the bakri had leaked out of the balloon.Another bakri was used to complete the procedure and achieve hemostasis.The volume of blood loss was noted to be determined from heart rate, shock rate, and blood pressure.Although, the customer facility declined to provide the blood loss volume information since it was part of the patient's confidential clinical history.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Additional information: b5.Investigation ¿ evaluation: a visual inspection and functional test of the returned device was performed.Visual examination confirmed the balloon catheter, only, was returned in used condition.The stopcock was attached to the inflation line.There were no visible anomalies observed on the catheter.A functional test was performed on the open device by inflating the balloon with 150ml of tap water.The inflated balloon noted no leaks in the material or at the bonds.There was no leakage between the catheter lumens or from the stopcock when in the closed position.The event as reported could not be recreated.The returned sample functioned as intended.Cook could not determine a definitive cause of this reported failure.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.

• 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: 9536144
• MDR Text Key: 173231586
• Report Number: 1820334-2019-03182
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)220710(10)9869380
• 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: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2022
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 9869380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1