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

Model Number 7005

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The balloon was tightly folded.There were numerous hypotube kinks.The hypotube was separated 19.5cm from the hub.The separated ends of the hypotube was ovaled indicating the hypotube was kinked prior to separating.

Event Description

Reportable based on device analysis completed on 10jan2020.It was reported that shaft kink occurred.The 93% stenosed, 4x10mm target lesion was located in moderately tortuous and moderately calcified left anterior descending artery.A 4.0mm x 8mm quantum maverick balloon catheter was advanced for dilatation.However, during procedure the balloon delivery shaft was kinked.The procedure was completed with different device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed shaft detached/separation.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9643313
• MDR Text Key: 178641155
• Report Number: 2134265-2020-00686
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392606
• UDI-Public: 08714729392606
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2022
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0023547793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2019
• 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: 48 YR
• Patient Weight: 78