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

Model Number 7015

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: hospital affiliated to school of medicine, (b)(6).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 kinks 12cm and 14.9cm distal from the strain relief.The balloon was loosely folded.Microscopic inspection revealed tip damage.There was a longitudinal tear 1mm long starting 2mm proximal from the proximal marker band.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based on device analysis completed on (b)(6) 2021.It was reported that shaft kink occurred.The target lesion was located in the left circumflex artery.A 3.0mm x 15mm quantum maverick balloon catheter was advanced for dilation.However, during procedure, it was noted that the balloon delivery shaft was kinked.The procedure was completed with another of the same device.There were no patient complications and the patient was stable.However, returned device analysis revealed balloon longitudinal tear.

• 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: 11565669
• MDR Text Key: 244444525
• Report Number: 2134265-2021-03856
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392781
• UDI-Public: 08714729392781
• 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: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2023
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0025346537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2020
• 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: 52 YR
• Patient Weight: 78