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

Model Number	7010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that shaft break occurred.The 75% stenosed target lesion was located in the mildly tortuous and mildly calcified mid and distal right coronary artery.A 2.75mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, the middle of the device delivery shaft was fractured.The fractured part was simply pulled out and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.
Event or Problem Description
It was reported that shaft break occurred.The 75% stenosed target lesion was located in the mildly tortuous and mildly calcified mid and distal right coronary artery.A 2.75mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, the middle of the device delivery shaft was fractured.The fractured part was simply pulled out and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter in the packaging hoop.The balloon was tightly folded.Analysis of the tip, balloon, inner/outer shaft, and hypotube included microscopic and visual inspection.Inspection found no damage or defect with the returned device.The reported fracture was not confirmed.

• 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: 10920965
• Report Number: 2134265-2020-16441
• Device Sequence Number: 2671627
• Product Code: LOX
• UDI-Device Identifier: 08714729392668
• UDI-Public: 08714729392668
• 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): 12/23/2020

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: 07/24/2022
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0024161813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2020
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 11/30/2020
• Supplement Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1