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 11/16/2017

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 user facility reported post cesarean section procedure, the patient experienced postpartum hemorrhaging due to central placenta previa.The patient lost 700 ml of blood before placement of the bakri tamponade balloon catheter.In addition, the patient was injected with carbetocin injection 100ug and hemabate injection 250ug which had no effect on the patient.The physician placed the balloon transabdominally.When using the enclosed syringe to fill the balloon with 250ml, the balloon ruptured and the saline flowed out.The physician then removed the balloon and found the balloon longitudinal cracked about 3cm.The physician proceeded with using another device and the bleeding successfully stopped.No unintended portion of the device remained inside the patient¿s body.No additional procedures were required due to this occurrence.No adverse effects or consequences were reported to the patient due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: the investigation included a review of drawings, quality control data, and specifications.A visual inspection of the returned device was also conducted.One bakri tamponade balloon catheter was returned for evaluation.The balloon catheter was returned with bio matter on the device.A visual examination noted the balloon has a split in the material that measures approximately 6 cm in length.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 device history record was reviewed and there were no non-conformances noted that would have caused or contributed to the reported event.A review of complaint history for this product/lot number combination revealed there have been no other complaints received associated with complaint lot number 7434928.Based on the provided information, examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.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: 7067237
• MDR Text Key: 93212800
• Report Number: 1820334-2017-04188
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)191110(10)7434928
• 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,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 11/29/2017
• Supplement Dates Manufacturer Received: 12/15/2017
• Supplement Dates FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other
• Patient Age: 36 YR
• Patient Weight: 70