MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 7015

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

Age at the time of event: 18 years or older.

Event Description

It was reported that shaft break occurred.The 98% stenosed, 20mmx2.75mm target lesion was located in the severely tortuous and severely calcified right cronary artery.A 3.0mm x 15mm quantum maverick balloon was advanced for dilatation.However, the shaft was kinked and upon removal, the shaft was fractured outside the patient's body.The procedure was completed with a different device.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

Age at the time of event: 18 years or older.Device evaluated by mfr.: the device was returned for analysis.Returned product consisted of a quantum maverick mr balloon catheter, in two pieces.The balloon was tightly folded.Analysis of the tip, balloon, inner/outer shaft and hypotube included microscopic and visual inspection.Inspection revealed a complete separation in the hypotube that was located 68.2cm from the strain relief, and there were numerous kinks in the hypotube.Inspection of the rest of the device found no other damage or defects.

Event Description

It was reported that shaft break occurred.The 98% stenosed, 20mmx2.75mm target lesion was located in the severely tortuous and severely calcified right cronary artery.A 3.0mm x 15mm quantum maverick balloon was advanced for dilatation.However, the shaft was kinked and upon removal, the shaft was fractured outside the patient's body.The procedure was completed with a different device.There were no patient complications reported and the patient status was stable.

• Brand Name: QUANTUM MAVERICK
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10969209
• MDR Text Key: 220242621
• Report Number: 2134265-2020-17168
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392781
• UDI-Public: 08714729392781
• Combination Product (y/n): N
• PMA/PMN Number: P860019
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0024978952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1