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

Model Number 7010

Device Problem Break (1069)

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

Event Date 05/20/2019

Event Type  malfunction  

Event Description

It was reported that shaft break occured.The 50% stenosed target lesion was located in the mildy tortuous and severely calcified left anterior descending artery.A 4.0 mm x 12 mm quantum maverick balloon catheter was advanced for dilation.However, the shaft broke over 15 cm from the hub.The device was completely removed from the patient's body without any medical intervention performed.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 81.3cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that shaft break occured.The 50% stenosed target lesion was located in the mildy tortuous and severely calcified left anterior descending artery.A 4.0mm x 12mm quantum maverick balloon catheter was advanced for dilation.However, the shaft broke over 15cm from the hub.The device was completely removed from the patient's body without any medical intervention performed.No patient complications were reported and the patient's 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: 8693123
• MDR Text Key: 147808321
• Report Number: 2134265-2019-06131
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392712
• UDI-Public: 08714729392712
• 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: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0023130394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Date Manufacturer Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 62