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

Model Number	7015
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation by mfr: returned product consisted of a quantum maverick balloon catheter.The device was visually and microscopically examined.At 63cm from strain relief, the hypotube was separated.The separated ends of the hypotube were ovaled in shape indicating the device was kinked prior to separation.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded and had contrast and blood present in the folds.
Event or Problem Description
Reportable based on device analysis completed on 18-oct-2021.It was reported that shaft kink occurred.The 95% stenosed, 2.75mm x 18mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.75mm x 15mm quantum maverick balloon catheter was advanced for dilatation however, during the procedure, the delivery shaft was kinked.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.However, returned device analysis revealed separated hypotube.

• Brand Name: QUANTUM MAVERICK
• Common Device Name: 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: 12775831
• Report Number: 2134265-2021-13320
• Device Sequence Number: 6120068
• Product Code: LOX
• UDI-Device Identifier: 08714729392774
• UDI-Public: 08714729392774
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/08/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2023
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0026183046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 75 KG