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

Model Number 24658

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a balloon rupture occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified right superficial femoral artery.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 6atm.The device was simply removed from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient was good post procedure.

Manufacturer Narrative

(b)(6).Device evaluated by manufacturer: the device was returned for analysis.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 a boston scientific encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 7mm distal to the distal end of the proximal markerband.An examination of the balloon material and markerband identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 12atm.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 the hypotube of the device to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.No issues were noted with the shaft polymer extrusion.No other issues were identified during the product analysis.

Event Description

It was reported that a balloon rupture occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified right superficial femoral artery.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 6atm.The device was simply removed from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient was good post procedure.

• Brand Name: SMALL PERIPHERAL 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: 9359881
• MDR Text Key: 173505423
• Report Number: 2134265-2019-14310
• Device Sequence Number: 1
• Product Code: NWX
• 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: 12/17/2019

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 Expiration Date: 01/23/2021
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0021653284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1