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 12/13/2019

Event Type  Malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that balloon rupture occurred. The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery. A 5. 00mm/2. 0cm/90cm peripheral cutting balloon was selected for use. During procedure, it was noted that the balloon ruptured upon second dilatation at 6atm. The device was simply removed from the patient's body. The procedure was completed with another of the same device. No complications reported and 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9526558
• MDR Text Key: 177141301
• Report Number: 2134265-2019-16228
• 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

• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/27/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 24630
• Device Catalogue Number: 24630
• Device LOT Number: 0023801848
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/29/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 05/16/2019
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial