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

Model Number 3822

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by the manufacturer: the device was returned for analysis a visual examination identified that there was blood in the balloon material which suggests that there is a leak in the device.The returned device was attached to an encore inflation unit and the device was subjected to positive pressure, liquid was observed to be leaking from a balloon pinhole detected at the distal edge of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and tactile examination of the hypotube was completed.No damage or any issues were noted with the hypotube that could have contributed to the complaint incident.A visual and tactile examination identified no issues with the shaft which may have potentially contributed to the complaint incident.No damage or any issues were noted with the polymer extrusion shaft that could have contributed to the complaint incident.A visual and microscopic examination of the markerbands was completed.There was no burrs or uneven edges observed on the markerbands.No damage or any issues were noted with the markerbands that could have contributed to the complaint incident.No damage or any issues were noted with the tip that could have contributed to the complaint incident.A visual and microscopic examination observed no damage to the tip or blades.All blades were intact and fully bonded to the balloon surface.No damage or any issues were noted with the blades that could have contributed to the complaint incident.

Event Description

Reportable based on device analysis completed on 23aug2019.It was reported that the material could not be conformed.A 10/2.50 flextome cutting balloon was selected for use.It was noted that the material could not be used in accordance to its function.However, device analysis revealed that there was a leak in the device.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; model farm road; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9078722
• MDR Text Key: 158896727
• Report Number: 2134265-2019-10991
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/17/2019

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: Other
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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