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

Model Number 7015

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2019

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.The target lesion was located in the coronary artery.A 3.0mm x 15mm quantum maverick balloon cathether was selected for use.However, it was noted that the device was fractured during the procedure.No patient complications were reported.

Event Description

It was reported that shaft break occurred.The target lesion was located in the coronary artery.A 3.0mm x 15mm quantum maverick balloon catheter was selected for use.However, it was noted that the device was fractured during the procedure.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a quantum maverick catheter in three pieces.The balloon was tightly folded.The tip, balloon, inner/outer shaft, and hypotube were microscopically and visually inspected.Inspection revealed hypotube/shaft fractures located at 25cm from the tip and 55 cm from the strain relief.The fracture faces located at 55cm from the strain relief were ovalized, as if kinked prior to separation, and the fracture faces located near the port weld, both shaft and hypotube separated were pinched as if separated mechanically.Inspection of the rest of the device found no damage or defect with the device.The reported fracture was confirmed.

• 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: 8566205
• MDR Text Key: 143599200
• Report Number: 2134265-2019-04563
• 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: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2021
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0022588655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 105