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

Model Number 7590

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed a kink on the hypotube 87cm from the hub.The inflation lumen is stretched 3cm from the tip and is approximately 8.5cm long.The guidewire lumen is stretched 3mm from the tip and is approximately 11cm long.Microscopic examination revealed a longitudinal tear in the balloon 4mm from the tip and approximately 1mm long.There is a pattern on the balloon leading to the hole in the balloon.The marker band appears to be more distal than normal.The balloon is loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the hypotube is kinked.

Event Description

Reportable based on device analysis completed on (b)(6) 2019 it was reported that shaft kink occurred.The 88% stenosed, 21mmx2.0mm target lesion was located in the moderately tortuous and calcified left anterior descending artery.A 2.00mm x 20mm maverick balloon catheter was selected for use.However, it was noted that the balloon delivery shaft got kinked 80cm from the physician's hand to the kink point.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed balloon torn longitudinal.

• Brand Name: MAVERICK
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8469895
• MDR Text Key: 140498366
• Report Number: 2134265-2019-03281
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729370161
• UDI-Public: 08714729370161
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2021
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 22201335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 68