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

Model Number H749CBM3300150

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.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 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.Liquid was observed to be leaking from a balloon pinhole 0.9mm proximal from the proximal end of the distal 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.This type of damage is consistent with excessive force being applied to the delivery system.No other issues were found during product analysis.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

Reportable based on device analysis completed on 19apr2016.It was reported that catheter balloon leak occurred.The target lesion was located in the coronary artery.A 15/3.00 flextome cutting balloon catheter was selected for use.During procedure, the physician inserted the catheter and inflate it up in the vessel; however, it was noted that there was a drip on the balloon that was going up at nominal.The physician then deflated the system and brought the balloon out.The balloon was again inflated and the physician noted that there was a slight leaking on the device.The device was completely removed from the patient.The procedure was completed with an unspecified balloon catheter.No patient complications were reported and the patient's status is fine.However, device analysis revealed a balloon pinhole 0.9mm proximal from the proximal end of the distal markerband.

• 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: 5654605
• MDR Text Key: 45198099
• Report Number: 2134265-2016-03818
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2016

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: 08/10/2018
• Device Model Number: H749CBM3300150
• Device Catalogue Number: CBM330015
• Device Lot Number: 0018284470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2015
• 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
• Patient Age: 46 YR