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

Model Number N/A

Device Problem Leak/Splash (1354)

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

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported a bakri tamponade balloon catheter was used for postpartum bleeding and the physician noted the saline was flowing out from the drainage catheter.The possibility of metrorrhexis was ruled out ultrasonically.The physician removed the device and found the balloon was flat due to the leakage/damage.A new device was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation - evaluation: one bakri tamponade balloon catheter was returned/received for an evaluation.A functional test was performed.The balloon was inflated with water and no leaks were observed.The customer report of a balloon leak could not be recreated in the lab and therefore could not be confirmed.Based on the information available a definitive root cause cannot be established.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record showed there were no non-conformance's identified during the manufacturing process that would have caused or contributed to the reported product issue.A review of complaint history for this product and lot number combination revealed this is the only complaint associated with this lot number.Per the quality engineering risk assessment; no further action is required.Cook medical has notified the appropriate personnel and the will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6188726
• MDR Text Key: 62855151
• Report Number: 1820334-2016-01504
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)190705(10)7094240
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-SOS-100500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/25/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: 08/16/2017
• Supplement Dates FDA Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2016
• 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 Age: 34 DA
• Patient Weight: 70