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

Model Number H749RB4250100

Device Problem Inflation Problem (1310)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: 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 inflation device 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.After soaking, positive pressure was again applied when liquid was observed to be leaking from a balloon pinhole over the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.All blades were present and fully bonded to the balloon surface.No issues were noted with the tip of the device.The hypotube was kinked at several locations along its length.This type of damage is consistent with excessive force being applied to the delivery system.No other issues were identified during the 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 the product analysis completed on november 23, 2015.It was reported inflation failed.During the use of a flextome cutting balloon, the physician noticed that the balloon would not hold pressure inside the patient.The device was removed from the patient and another of the same was used to complete the procedure.No patient complications were reported.However, the returned product analysis revealed a pinhole.

• 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: 5301607
• MDR Text Key: 34328910
• Report Number: 2134265-2015-08596
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2015

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: 06/07/2018
• Device Model Number: H749RB4250100
• Device Catalogue Number: RB425010
• Device Lot Number: 0018069280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2015
• 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