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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.00mmx1.5cmx140cm small peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at below rated burst pressure.The procedure was completed with a different device.No complications were reported and there was no patient injury.

Event Description

It was reported that a balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.00mmx1.5cmx140cm small peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at below rated burst pressure.The procedure was completed with a different device.No complications were reported and there was no patient injury.It was further reported that the balloon was completely removed from the patient's body.

• 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: 11237007
• MDR Text Key: 228900621
• Report Number: 2134265-2021-00845
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• PMA/PMN Number: P950020
• 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: 02/25/2021

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: 05/12/2023
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0025506201
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1