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 11/15/2019

Event Type  malfunction  

Event Description

It was reported that balloon ruptured.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, it was noted that balloon rupture occurred.The procedure was completed with a different device.No complications reported.

Manufacturer Narrative

Corrected aware date from 11/21/2019 to 11/20/2019.Corrected event date from (b)(6) 2019.

Event Description

It was reported that balloon ruptured.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.00mm/ 1.5cm/ 140cm small peripheral cutting balloon was selected for use.During the procedure, it was noted that balloon rupture occurred.The procedure was completed with a different device.No complications reported.It was further reported that the device was simply pulled out of the patient's body and that 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: 9419051
• MDR Text Key: 169730747
• Report Number: 2134265-2019-15099
• 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: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0023923356
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE- TREASUREXS; GUIDEWIRE- TREASUREXS; INTRODUCER SHEATH- DESTINATION; INTRODUCER SHEATH- DESTINATION