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

Catalog Number J-SOS-100500

Device Problems Inflation Problem (1310); Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: k170622.(b)(4).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 initially reported, the bakri tamponade balloon had a hole in it and could not inflate properly.Additional information was received on (b)(6) 2018.The bakri had hole in it upon removal from packaging and therefore would not inflate.They have discarded the item and used another.The device was used post-delivery to reduce risk associated with postpartum hemorrhage (pph).A second bakri was used to complete the procedure.Additional patient and event details have been requested.No further information has been provided at the time of this report.

Event Description

There has been no new information received since the last report was submitted.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.The complaint device was not returned for an evaluation and no photograph was provided.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of complaint history, the device history record, drawings, instructions for use, quality control data, and trends.A review of the device history observed no non-conformances that would have caused or contributed to the reported failure mode.A review of complaint history records revealed this is the only complaint associated with the complaint device lot number 9229923.This device is shipped with the instructions for use (ifu) which contains the proper warnings, precautions, and instructions for use.A conclusion as to the cause of the reported issue could not be established with the available information.Measures have been initiated to address this failure mode.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: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8129969
• MDR Text Key: 129782445
• Report Number: 1820334-2018-03511
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)211011(10)9229923
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2021
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 9229923
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1