MAUDE Adverse Event Report: COOK INC CODA LP BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number N/A

Device Problem Material Rupture (1546)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 08/11/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).Event is still under investigation at this time.

Event Description

As per mhra report: a male patient of large body habitus and having vascular tortuosity and calcification, underwent elective transfemoral transcatheter aortic valve implantation (tavi) on the (b)(6) 2015.Bilateral femoral arterial access was obtained uneventfully and a 16 french sheath placed in the left femoral artery to deliver the tavi device.Two percutaneous suture closure devices from another manufacturer were utilized for pre-closure of the left femoral arterial puncture site.There was a technical issue with the first delivery device; which was unsuitable for deployment, but this was subsequently exchanged for a 2nd delivery system allowing satisfactorily deployment of a 29 mm valve in the aortic position with good function and no complications.The other manufacturer's closure devices were initially deployed following sheath removal; but were unsuccessful in controlling brisk hemorrhage.Manual pressure was therefore, utilized to control the bleeding, but this was difficult due to the large body habitus.Contralateral access from the right femoral artery was used to attempt delivery of an iliac occlusion balloon to arrest bleeding and allow surgical repair.This maneuver was unsuccessful due to vascular tortuosity and calcification.An aortic balloon was inflated slowly in the distal abdominal aorta with frequent checks for control of distal bleeding.This balloon ruptured just as control of distal bleeding was achieved resulting in a tear of the lower abdominal aorta and massive intra-abdominal hemorrhage (1820334-2015-00662).Transfusion protocol was initiated and patient received a large volume of colloids and packed red cells.Arrest of bleeding was then achieved with a second aortic balloon in the thoracic descending aorta.Stent deployment at the site of abdominal aortic rupture was contemplated but felt futile in view of prolonged hypotension and an agonal cardiac rhythm.The patient expired.Although requested, no additional information has been provided at this time.

Manufacturer Narrative

(b)(4).Investigation/evaluation: no images or device were returned; however, during the course of investigation, a review of the complaint history, device history record, drawing, instructions for use (ifu), quality control, and trends was conducted.Balloon and fatigue design verification testing of the balloon showed the device was capable of meeting design input requirements.Maximum inflation volume is documented on label as well as ifu.The ifu also warns to adhere to balloon inflation parameters and always monitor balloon inflation under fluoroscopic control.It was determined that the most likely cause of this failure mode is due to over inflation.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.The appropriate internal personnel will be notified and will continue to monitor for similar complaints.

Event Description

As per (b)(6) report: a male patient of large body habitus and having vascular tortuosity and calcification, underwent elective transfemoral transcatheter aortic valve implantation (tavi) on the (b)(6) 2015.Bilateral femoral arterial access was obtained uneventfully and a 16 french sheath placed in the left femoral artery to deliver the tavi device.Two percutaneous suture closure devices from another manufacturer were utilized for pre-closure of the left femoral arterial puncture site.There was a technical issue with the first delivery device; which was unsuitable for deployment, but this was subsequently exchanged for a 2nd delivery system allowing satisfactorily deployment of a 29 mm valve in the aortic position with good function and no complications.The other manufacturer's closure devices were initially deployed following sheath removal; but were unsuccessful in controlling brisk hemorrhage.Manual pressure was therefore, utilized to control the bleeding, but this was difficult due to the large body habitus.Contralateral access from the right femoral artery was used to attempt delivery of an iliac occlusion balloon to arrest bleeding and allow surgical repair.This maneuver was unsuccessful due to vascular tortuosity and calcification.An aortic balloon was inflated slowly in the distal abdominal aorta with frequent checks for control of distal bleeding.This balloon ruptured just as control of distal bleeding was achieved resulting in a tear of the lower abdominal aorta and massive intra-abdominal hemorrhage (1820334-2015-00662).Transfusion protocol was initiated and patient received a large volume of colloids and packed red cells.Arrest of bleeding was then achieved with a second aortic balloon in the thoracic descending aorta.Stent deployment at the site of abdominal aortic rupture was contemplated but felt futile in view of prolonged hypotension and an agonal cardiac rhythm.The patient expired.Although requested, no additional information has been provided at this time.

• Brand Name: CODA LP BALLOON CATHETER
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5161547
• MDR Text Key: 28726561
• Report Number: 1820334-2015-00662
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K032869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CODA-2-9.0-35-120-32
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/11/2015
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death