MAUDE Adverse Event Report: COOK INC ATB ADVANCE BALLOON CATHETER; DQY CATHER, PERCUTANEOUS

Catalog Number ATB5-35-80-14-4.0

Device Problem Balloon rupture (1049)

Patient Problem Foreign body, removal of (2365)

Event Date 01/15/2015

Event Type  Injury  

Event Description

During a pta of subclavian, the physician inflated the device twice with no incident.On the third circumferential rupture, all fragments were able to be removed.There was no harm to the patient.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

(b)(4).The device was not returned for investigation.The balloon was undergone burst, compliance, and fatigue verification testing.There is no evidence to suggest that the device wa snot manufactured to specs.The device is supplied with an ifu which is the proper indications, warnings, precautions, contraindications, and proper usage techniques including inflation/deflation and device removal methods.The related burst pressure (rbp) is listed on the ifu and the labeling.For this specific rpn, the nominal pressure is 5 atm/bar and the rbp is 8 atm/bar.Depending on the pt's anatomy, anatomy could have played a role in the separation that occurred after rupture, but his cannot be confirmed.Also, if the device attempted to be withdrawn through a sheath or introducer following rupture, the sheath or introducer could have caused difficult removal and aided in the separation, but this cannot be confirmed.Without return of the complaint device and without knowing more info (pt anatomy, inflation pressure, if a sheath was used and how the device was removed), a definite root cause cannot be determined.We have notified appropriate internal personnel and will continue to monitor for similar complaints.

Event Description

During a percutaneous transluminal angioplasty of subclavian, the physician inflated the device twice with no incident.On the third inflation, there was a circumferential rupture.All fragments were able to be removed.There was no harm to the pt and no add'l procedures or intervention was required.

• Brand Name: ATB ADVANCE BALLOON CATHETER
• Type of Device: DQY CATHER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; bloomington IN 47404
• Manufacturer Contact: larry pool, manager ; 750 daniels way; p.o. box 489; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4491336
• MDR Text Key: 5328579
• Report Number: 1820334-2015-00062
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00827002441453
• UDI-Public: (01)00827002441453(17)161107(10)5428378
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2016
• Device Catalogue Number: ATB5-35-80-14-4.0
• Device Lot Number: 5428378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/15/2015
• Device Age: 1 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2014
• 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): Required Intervention