MAUDE Adverse Event Report: COOK INC ADVANCE 35 LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number PTA5-35-80-8-6.0

Device Problem Break (1069)

Patient Problem Foreign body, removal of (2365)

Event Date 12/16/2014

Event Type  Injury  

Event Description

Ir doctors 2x ptz balloons were placing 'kissing' in the common illiacs (length of illiacs between 7-9cm) and inflated for approx 15mins to 10atm after birth (cesarean) while the uterus and placenta were being investigated.After the uterus had been sown the 2x pta balloons were deflated by the ir doctors and left in-situ while the cesarean was being closed by the obstetricians (the ir team had left the patient with the obstetricians).Approx 30 mins later the ir team was recalled to remove the deflated pta balloons.A rn nurse then successfully removed the pta balloon from the right illiac without incident.The nurse then attempted to remove the pta balloon and encountered resistance presuming that the pta balloon was caught on the distal tip of the sheath.The cid was then attached to the pta balloon catheter broke/snapped at the distal end of the sheath.The ir team were immediately called and the patient was then sent for screening and it was observed that the pta balloon catheter had broke/snapped and did appear that the balloon was fully deflated.The ir team then attempted to retrieve the broken part of the pta balloon that had remained in the body by going in to tight illiac.This was unsuccessful and accordingly the patient was moved to operating theatres and open surgery was performed to remove the remaining part of the pta balloon.

Manufacturer Narrative

(b)(4).

• Brand Name: ADVANCE 35 LOW PROFILE BALLOON CATHETER
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; bloomington IN 47404
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4434232
• MDR Text Key: 5374768
• Report Number: 1820334-2015-00055
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K091527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 06/01/2017
• Device Catalogue Number: PTA5-35-80-8-6.0
• Device Lot Number: 5068625
• Other Device ID Number: UDI#: (01)10827002523606(17)17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/16/2014
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 31 YR
• Patient Weight: 50