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

Catalog Number J-SOS-100500

Device Problems Break (1069); Inflation Problem (1310)

Patient Problems Hemorrhage/Bleeding (1888); Blood Loss (2597); No Code Available (3191)

Event Date 08/29/2017

Event Type  malfunction  

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

As reported by the user facility, a cesarean section was performed with the (b)(6)-year-old female patient due to fetal macrosomia.Before placing the bakri tamponade balloon catheter to treat postpartum hemorrhage, the amount of bleeding reached 1000 ml due to uterine atony.The physician had used oxytocin, carbetocin, and carboprost tromethamine to promote contraction of the womb but failed.Therefore, the bakri balloon was used to stop bleeding.An assistant held the balloon placed into the uterine cavity through the vagina, then the doctor filled it with 100 ml water.The assistant found the water was back flowing to the catheter and the balloon could not be inflated.The physician moved out the device and found the front of the catheter was broken.With bilateral ascending uterine artery ligation and uterine binding method the bleeding was successfully stopped.As reported, a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation - evaluation: a review of the device history record, drawings, documentation, quality control, and specifications was performed.A visual inspection and functional testing of the returned device was also conducted during the investigation.One bakri tamponade balloon catheter was returned for evaluation.A functional test noted a leak in the balloon.Using magnification, the balloon material has grasper marks on the material where the hole is located.It appears that during the procedure, the instrument used to maneuver the device has penetrated the wall of the material, causing a hole in the balloon material surface.The complaint is confirmed.There is no indication that a design or process related failure mode contributed to this event.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 two non-conformances were identified.These non-conformances are not related to the reported failure mode of this complaint.A review of complaint history revealed there have been no other complaints associated with this complaint device lot number 7919727.Based on the information provided, the root cause is likely due to user technique.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: 6865101
• MDR Text Key: 86139689
• Report Number: 1820334-2017-02973
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)200517(10)7919727
• 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: 12/01/2017

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: 09/11/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 11/09/2017
• Supplement Dates FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2017
• 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: 40 YR
• Patient Weight: 85