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

Model Number 24634

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2019

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in a moderately tortuous and severely calcified common femoral artery to superficial femoral artery.A 4.00mm/1.5cm/140cm small peripheral cutting balloon and a 6.00mm/2.0cm/135cm peripheral cutting balloon were selected for use.During the procedure, a non bsc guidewire was advanced; however, it failed to cross the lesion.After several attempts, the wire eventually crossed the lesion and then dilation was performed with the 4mm small peripheral cutting balloon.However, during second inflation, it was noted that the balloon ruptured at 6atm.Subsequently, the 6mm peripheral cutting balloon was used; however, during second inflation, the balloon ruptured at 10atm.The devices were simply removed from the patient's body.The procedure was completed with a different device.No patient complications were reported and the patient was good post procedure.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9332365
• MDR Text Key: 173347211
• Report Number: 2134265-2019-13940
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2019

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: Health Professional
• Device Expiration Date: 01/27/2021
• Device Model Number: 24634
• Device Catalogue Number: 24634
• Device Lot Number: 0023252457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2019
• 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