MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY FLEXTOME¿ CUTTING BALLOON¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H749RB4250100

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that balloon rupture occurred.The moderately tortuous and moderately calcified target lesion was located in the middle of left anterior descending artery.A 10/2.50 flextome cutting balloon was used for pre- dilation.When dilatation was performed at 6 atm on 1st inflation for 20 seconds, pressure decreased suddenly, it was noted that the balloon ruptured and the device was removed.No patient complications were reported and patient's condition was good.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and inflation lumen which is evidence of a device leak.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon could not be inflated due to the solidified blood present within the balloon and inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees to help soften the solidified blood before further inflation attempts were made.The device was attached to an inflation device, subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole at 0.5 mm distal to the distal end of the proximal markerband.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.A visual and tactile examination found that the hypotube was kinked at various positions along its length.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that balloon rupture occurred.The moderately tortuous and moderately calcified target lesion was located in the middle of left anterior descending artery.A 10/2.50 flextome¿ cutting balloon¿ was used for pre- dilation.When dilatation was performed at 6 atm on 1st inflation for 20 seconds, pressure decreased suddenly, it was noted that the balloon ruptured and the device was removed.No patient complications were reported and patients condition was good.

• Brand Name: FLEXTOME¿ CUTTING BALLOON¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5306763
• MDR Text Key: 33769212
• Report Number: 2134265-2015-08738
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2018
• Device Model Number: H749RB4250100
• Device Catalogue Number: RB425010
• Device Lot Number: 17623028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2015
• 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