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

Model Number G30673

Device Problem Material Rupture (1546)

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

Event Date 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

E3: occupation: unknown.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 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.

Event Description

As reported, while testing the 'bakri tamponade balloon catheter' the balloon ruptured, prior to an unspecified procedure.The balloon was injected with 10ml of normal saline and the device functioned as normal.When the saline was injected into the balloon to 30ml, the balloon ruptured.There was 300ml of blood loss before the device failure.The amount of blood loss total is unknown.The procedure was complete with another same-like device.There were no effects on the patient.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: a representative of guangzhou mokin med.Inst.Co.Informed cook on 28jun2023 of an incident involving a cook bakri postpartum balloon (j-sos-100500) from production lot 14483381.As reported, while testing the bakri tamponade balloon catheter prior to an unspecified procedure, the balloon ruptured.The balloon was injected with 10ml of normal saline and the device functioned as normal.When the saline was injected into the balloon to 30ml, the balloon ruptured.There was 300ml of blood loss before the device failure.The amount of blood loss total is unknown.The procedure was completed with another same-like device.No adverse effects were reported.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control (qc) procedures were conducted during the investigation.One bakri tamponade balloon catheter was returned for investigation.Visual inspection confirmed that the balloon material was split nearly the entire length of the balloon.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A search of the device history record found no related non-conformances reported for lot 14483381.A complaint history database search showed no other related complaints associated with the failure mode for the complaint device for lot 14483381.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 ifu [t_j-sosr_rev4; 'bakri postpartum balloon'] supplied with the device states the following in consideration of the reported failure mode: "how supplied: upon removal from the package, inspect the product to ensure no damage has occurred." review of the device history record, complaint history, quality control documents, and device failure analysis does not indicate that the device was manufactured out of specification and does not suggest items in the lot or similar devices in the field or in house are nonconforming.The complaint was confirmed based on customer testimony and evaluation of the returned device.Based upon the available information and results of the investigation, cook has concluded that the cause for the complaint could not be established.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.

Event Description

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

• 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: 17326803
• MDR Text Key: 319880270
• Report Number: 1820334-2023-00902
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)250119(10)14483381
• 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,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 14483381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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