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

Model Number	7010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed, 3.5mmx13mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 3.5mm x 12mm quantum maverick balloon catheter was advanced for dilation.However, on the first inflation at 15 atmospheres for 20 seconds, the balloon ruptured.The ruptured part did not remain in the patient's body.The procedure was completed with another of the same device.There were no patient complications reported and patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.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.The balloon was loosely folded.Microscopic inspection revealed tip damage.The device was soaked in a water bath for one day to loosen the blood and contrast in the device.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole 1mm distal from the distal marker band.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed, 3.5mmx13mm target lesion was located in the moderatey tortuous and moderately calcified left anterior descending artery.A 3.5mm x 12mm quantum maverick balloon catheter was advanced for dilation.However, on the first inflation at 15 atmospheres for 20 seconds, the balloon ruptured.The ruptured part did not remain in the patient's body.The procedure was completed with another of the same device.There were no patient complications reported and patient's status was stable.

• 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: 10954494
• Report Number: 2134265-2020-17012
• Device Sequence Number: 2885166
• Product Code: LOX
• UDI-Device Identifier: 08714729392699
• UDI-Public: 08714729392699
• 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
• Report Date (Section B): 01/20/2021

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: 10/21/2022
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0024636450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2020
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 82