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

Catalog Number J-SOS-100500

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Name and address: postal code: (b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, in the last 2-3 months, the user inserted the bakri tamponade balloon catheter into the patient and injected water to inflate it.The blue handle of the stop cock came off from the base and sterile water leaked.They pushed the handle into the base, and it successfully attached, and the leak was resolved to complete the procedure.The patient did not experience any adverse effects due to this occurrence.Additional event information has been requested.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, in the last 2-3 months, the user inserted the bakri tamponade balloon catheter into the patient and injected water to inflate it.The blue handle of the stop cock came off from the base and sterile water leaked.They pushed the handle into the base, and it successfully attached, and the leak was resolved to complete the procedure.The patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the instructions for use (ifu) and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.However, cook received a complaint for the same product experiencing the same failure mode in complaint patient identifier: (b)(6) (1820334-2022-00181).The physical examination of the complaint device in found that damage to the stopcock appeared to be from unintended stress on the handle during operation by the user.Cook could not complete a review of the device history record (dhr) due to lack of lot information from the user facility.Cook could not complete a search of other complaints associated with the complaint device lot number due to lack of lot information from the user facility.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.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." cook has concluded a definitive cause of the reported incident could not be determined from the available information.The investigation under patient identifier: (b)(6) (1820334-2022-00181) concluded that a definitive cause of the event could not be determined from the available information.Because of similarities between the referenced complaint and the current complaint, it is likely that investigation of the complaint device would yield similar results.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 13474097
• MDR Text Key: 288500559
• Report Number: 1820334-2022-00172
• 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: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female