MAUDE Adverse Event Report: COOK INC BAKRI TAMPONADE BALLOON CATHETER; KNA INSTRUMENT, MANUAL, SPECIALIZED, OBSTETRIC-GYNECOLOGIC

Catalog Number J-SOS-100500

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The distributor reported post cesarean section procedure, the patient experienced postpartum hemorrhaging due to placenta previa.The patient had lost 1200ml of blood before the physician placed the bakri tamponade balloon catheter transabdominally.As explained, the physician placed the tamponade balloon, then sutured the uterus incision.When using the enclosed syringe to fill the balloon with 300ml, the balloon ruptured and the saline flowed out.The physician then removed the balloon and found the balloon was longitudinally cracked.The physician proceeded with using another device and the bleeding was successfully stopped.No unintended portion of the device remained inside the patient¿s body.No additional procedures were required due to this occurrence.No further adverse event occurred.The facility will not be returning the device due to the patient having an infectious disease.

Manufacturer Narrative

Investigation ¿ evaluation: the bakri tamponade balloon catheter was not returned for evaluation.Without the complaint device, a physical investigation was not able to be completed.A document-based investigation/evaluation was performed.A review of complaint history, the device history record, quality control data, and specifications was conducted.The device history record was reviewed and found there no non-conformances related to the reported failure.A review of complaint history for this product/lot number combination revealed this is the only complaint that has been received associated to complaint device lot number 7434920.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.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.The instructions for use (ifu) the proper warnings, precautions, and instructions for use.Based on the provided information and the investigation evaluation the actual root cause of this event is undeterminable.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: KNA INSTRUMENT, MANUAL, SPECIALIZED, OBSTETRIC-GYNECOLOGIC
• 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: 7138844
• MDR Text Key: 95514252
• Report Number: 1820334-2017-04430
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)191110(10)7434920
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K062438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: J-SOS-100500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 02/16/2018
• Supplement Dates FDA Received: 03/08/2018
• Date Device Manufactured: 11/10/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 32 DA
• Patient Weight: 72