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 11/07/2017

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 uterine inertia.The patient had lost 2000 ml of blood at the time and a bakri tamponade balloon catheter was placed transabdominally.In addition, the patient was injected with oxytocin and carboprost tromethamine intravenously.As explained, the physician passed the tamponade balloon, inflation port first, through the patient's uterus and cervix.The physician¿s assistant pulled the shaft of the balloon through the vaginal canal and then closed the incision per protocol.When using the enclosed syringe to fill the balloon with 200 ml, the balloon ruptured and the saline flowed out.Upon removal of the balloon, the physician found a longitudinal crack in the balloon.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 complaint history, the device history record, documentation, drawings, instructions for use, quality control data, and specifications.A visual inspection of the returned device was also conducted.One bakri tamponade balloon catheter was returned for evaluation.A visual examination noted there is a split in the balloon material that measures 6.5 cm with jagged edges.Also noted, there are scratches and grasper marks on the balloon material.The evidence of scratches and grasper marks on the balloon indicates the balloon was damaged during use.The complaint is confirmed.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 for this device lot number 7837260.A review of complaint history for this product/lot number combination revealed there have been two other complaints received.One for the reported issue of failure to inflate and another for failure to deflate.Both are associated with this reported failure.Based on the provided information and the investigation evaluation it is likely the balloon was damaged during use.However, a definitive root cause cannot 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: 7040709
• MDR Text Key: 92311182
• Report Number: 1820334-2017-04169
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)200417(10)7837260
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

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: 11/09/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 01/16/2018
• Supplement Dates FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2017
• 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: 28 DA
• Patient Weight: 65