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

Model Number	7015
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left main coronary artery.A 5.0mm x 15mm quantum maverick balloon catheter was advanced for use.However, when the physician gave pressure, the balloon ruptured.The procedure was completed with another of the same device.No patient complication were reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left main coronary artery.A 5.0mm x 15mm quantum maverick balloon catheter was advanced for use.However, when the physician gave pressure, the balloon ruptured.The procedure was completed with another of the same device.No patient complication were reported and the patient's status was stable.It was further reported that balloon ruptured during first inflation and was simply removed from the patient's body without any intervention.
Additional Manufacturer Narrative
Corrections: d4 lot number from 0023736538 to 002441079.D4 expiration date from 05/02/2022 to 09/10/2022.H4 device manufacture date:from 05/03/2019 to 09/11/2019.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 contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.There was a pinhole 4mm distal from the distal marker band.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported balloon ruptured.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left main coronary artery.A 5.0mm x 15mm quantum maverick balloon catheter was advanced for use.However, when the physician gave pressure, the balloon ruptured.The procedure was completed with another of the same device.No patient complication were reported and the patient's status was stable.It was further reported that balloon ruptured during first inflation and was simply removed from the patient's body without any intervention.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left main coronary artery.A 5.0mm x 15mm quantum maverick balloon catheter was advanced for use.However, when the physician gave pressure, the balloon ruptured.The procedure was completed with another of the same device.No patient complication were reported and the patient's status was stable.It was further reported that balloon ruptured during first inflation and was simply removed from the patient's body without any intervention.
Additional Manufacturer Narrative
Corrections: d4 lot number from 0023736538 to 002441079.D4 expiration date from 05/02/2022 to 09/10/2022.H4 device manufacture date:from 05/03/2019 to 09/11/2019.

• 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
• MDR Report Key: 10094359
• Report Number: 2134265-2020-07099
• Device Sequence Number: 16974303
• Product Code: LOX
• UDI-Device Identifier: 08714729392842
• UDI-Public: 08714729392842
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/14/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2022
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0024410779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 05/25/2020; 06/15/2020; 07/09/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 06/16/2020; 07/07/2020; 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 65