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

Model Number G24237

Device Problems Break (1069); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: compliance and customer service coordinator.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 is reported during an unspecified procedure using a cook bakri postpartum balloon with rapid instillation components, the user stated "there was an issue while inflating the balloon and evidence of liquid, requested new balloon." (unofficial translation of hand written information reported).The patient experienced no adverse effects as a result of this alleged product malfunction.The patient did not require any additional procedures as a result of the occurrence.No unintended section of the device remained inside the patient's body.Additional details regarding the patient and the event have been requested.At this time, no additional information has been provided.

Event Description

Additional information was received on 30may2019 stating the procedure performed was a "parto" procedure.Additionally, the patient weighed 71.6kg and was 160cm tall.Reportedly, the balloon was inflated to 500cc with saline but was "broken".After the difficulty with the cook device, the balloon was changed out and the procedure continued.

Manufacturer Narrative

Additional information: event, device code.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use (ifu), quality control, and trends of the device were conducted during the investigation.The complaint device was not returned.However, cook did receive a complaint for the same product experiencing a similar balloon leakage failure on complaint pr (b)(4).The physical examination of that device confirmed that the balloon did leak, and evidence of forceps marks were near the balloon material close to the pin holes.These markings helped to draw the conclusion of unintended use error as the main contributing factor.While that investigation was a helpful reference point for this event, as the current device was not returned, cook cannot confirm that this device was used in the same fashion.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with the device, which states ¿upon removal from the package, inspect the product to ensure no damage has occurred." based on the information provided and no product returned, investigation has concluded that a root cause for this event could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.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: 8640262
• MDR Text Key: 146081841
• Report Number: 1820334-2019-01264
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)211206(10)9363897
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2021
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 9363897
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 72