MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number 24630

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2019

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.The target lesion was located in the fistula in the hand.A 8.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.At the course of the procedure, when the physician tried to inflate the balloon, it was noted that water inside the balloon was coming out due to a hole.The device was simply removed from the patient's body.No patient complications were reported and the patient was perfect.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified no issues with device.The returned device was attached to an encore inflation device and subjected to positive pressure, liquid was observed to be leaking from a balloon pinhole located in the mid-section of balloon material.An examination of the balloon material 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

It was reported that a balloon rupture occurred.The target lesion was located in the fistula in the hand.A 8.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.At the course of the procedure, when the physician tried to inflate the balloon, it was noted that water inside the balloon was coming out due to a hole.The device was simply removed from the patient's body.No patient complications were reported and the patient was perfect.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9358241
• MDR Text Key: 173758182
• Report Number: 2134265-2019-14285
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• 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: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0023629247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Date Manufacturer Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1