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 12/06/2017

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 foreign distributor reported post cesarean section procedure, the patient experienced postpartum hemorrhage.The patient had lost 600 ml of blood and was injected with oxytocin.There was no effect from this.At that time the physician placed the bakri tamponade balloon catheter.As explained, the physician passed the tamponade balloon via the vagina and through the patient's uterus and cervix.When using the enclosed syringe to fill the balloon with 100 ml, the balloon ruptured and the saline flowed out.The physician then removed the balloon and found the balloon's circumference cracked.The physician proceeded with using another device and the bleeding was successfully stopped.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.No further adverse events to the patient were reported.

Manufacturer Narrative

Investigation ¿ evaluation: the investigation included a review of complaint history, the device history record, drawings, instructions for use, quality control data, and specifications.A visual inspection of the returned device was also conducted.One device was returned for investigation.A visual examination noted the balloon material has separated from the bond on the proximal end.The point of separation measured 1 cm width.Adhesive is visible and there appears to be cracks in the glue seam.The customer has stated the balloon had ruptured, however, the failure was a bond separation, there were no splits, tears, or damage on the balloon material except where the bond had separated on the proximal end of the balloon.The device history record was reviewed and there were no non-conformances noted for this device lot number 7434911.A review of complaint history revealed there have been no other complaints associated with the complaint device lot number 7434911.The instructions for use (ifu) states the proper warnings, precautions, and instructions for use.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.A definitive 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: 7138705
• MDR Text Key: 95512417
• Report Number: 1820334-2017-04427
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)191110(10)7434911
• 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: 04/09/2018

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: 12/08/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 03/12/2018
• Supplement Dates FDA Received: 04/09/2018
• 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): Required Intervention
• Patient Age: 28 YR
• Patient Weight: 70