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

Model Number 7015

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2020

Event Type  malfunction  

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 66.6cm distal of the strain relief.There was contrast in the inflation lumen.The balloon was tightly folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.The device was tested with an inflation device filled with water and was able to inflate to rated burst pressure and deflate with no difficulties.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported difficulties inflating the balloon.

Event Description

Reportable based on device analysis completed on 16-sep 2020.It was reported that inflation failure occurred.The 90% stenosed, 20mm x 4.5mm target lesion was located in the mildly tortuous and severely calcified right coronary artery.A 3.5mm x 15mm quantum maverick balloon catheter was advanced for dilatation.However, during procedure the physician found the stent could not stick well to the vessel as the balloon failed to inflate.The procedure was completed with another of same device.There were no patient's complications nor injuries reported and the patient's status was stable.However, returned device analysis revealed shaft detached/separated.

• 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: 10638016
• MDR Text Key: 210418772
• Report Number: 2134265-2020-13057
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392804
• UDI-Public: 08714729392804
• 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: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2022
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0024580586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2019
• 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: 61 YR
• Patient Weight: 59