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

Model Number 3822

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a balloon rupture occurred.The target lesion was located in the moderately calcified coronary artery.A 10/2.75 flextome cutting balloon was selected for use.During the procedure, blood was withdrawn in the non-inflated device when the air removal was performed inside patient's body.The balloon was ruptured.The procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for evaluation.Visual examination identified that the balloon was unfolded which indicates that the balloon had been 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 presence of solidified blood that was present within the inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the blood before further inflation attempts were made.The device was removed from the bath and the balloon was again attached to an inflation device subjected to positive pressure and liquid was observed to be leaking from a balloon longitudinal tear, which began at the distal edge of the proximal markerband and extended approximately 8mm distally across the balloon material.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this damage.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.No kinks or damage were noted along the shaft of the device.The rate of burst pressure of this flextome device is 12atm (atmospheres).No other issues were identified during the product analysis.(b)(6).

Event Description

It was reported that a balloon rupture occurred.The target lesion was located in the moderately calcified coronary artery.A 10/2.75 flextome cutting balloon was selected for use.During the procedure, blood was withdrawn in the non-inflated device when the air removal was performed inside patient's body.The balloon was ruptured.The procedure was completed with another of the same device.There were no patient complications reported.

• Brand Name: FLEXTOME CUTTING BALLOON
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8169220
• MDR Text Key: 130494628
• Report Number: 2134265-2018-64284
• 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
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

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: 04/29/2021
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0022054536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 01/04/2019
• Supplement Dates FDA Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1