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 12/24/2020

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.The 99% stenosed target lesion was located in the severely calcified superficial femoral artery.A 6.00mmx2.0cmx90cm peripheral cutting balloon was selected for use.During procedure, the balloon ruptured upon third inflation at 8 atmospheres for 5 seconds and there was a pinhole noted on the balloon.The device was removed from the patient's body without any problem using the normal method and the procedure was completed with a different device.No complications were reported and the patient was in good condition after the 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11123278
• MDR Text Key: 225285199
• Report Number: 2134265-2020-18801
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2021

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: 08/04/2022
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0025807586
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/25/2020
• Initial Date FDA Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• 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
• Treatment: GUIDEWIRE - JUPITERFC; INTRODUCER SHEATH - 6FR 45CM DESTINATION