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

Catalog Number J-SOS-100500

Device Problems Deflation Problem (1149); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2017

Event Type  malfunction  

Manufacturer Narrative

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, the bakri tamponade balloon catheter was used to stop uterine bleeding.The physician held the balloon with a pair of forceps and placed it into the uterine cavity through the vagina, then filled it out with 300 ml water, 60ml each time.Then the physician found that he could not continue to inject any more.However, the balloon was still too small to stop bleeding.The physician decided to remove the device but the physician could not draw the saline out from the balloon.Thus, the physician had remove the balloon by force.Finally, the physician changed to another new same balloon to finish the procedure successfully.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation.The investigation included a review of complaint history, the device history record, drawings, manufacturing instructions, quality control data, and specifications.A visual inspection and functional testing of the returned device was also conducted.One device was returned for investigation.The returned device had fluid in the balloon.The stopcock was moved to the open position and the water flowed out of the balloon.Using a syringe, fluid could be drawn through the stopcock.500 ml of water was then injected into the balloon and withdrawn from the balloon without any issue.The difficulty the customer experienced could not be recreated in the lab.The device history record was reviewed and there were no non-conformances noted for this device lot number.A review of complaint history revealed there have two other complaints associated with the complaint device lot number (7837260).However, neither of the two other complaints were similar or related to the failure mode - inflation difficulties.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 for the customer¿s difficulty 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: 6907202
• MDR Text Key: 88246312
• Report Number: 1820334-2017-03417
• 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,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 09/22/2017
• Initial Date FDA Received: 10/02/2017
• Supplement Dates Manufacturer Received: 03/02/2018
• Supplement Dates FDA Received: 03/28/2018
• 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: 37 YR
• Patient Weight: 68