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

Model Number	7005
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties were encountered.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified middle and distal end of right coronary artery.A 3.5mm x 8mm quantum maverick balloon catheter was advanced for dilation.The guidezilla guide extension catheter was lifted up however, it become stuck with the balloon and the balloon shaft was damaged.The device was simply removed nad the procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient's status was stable.
Additional Manufacturer Narrative
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.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found hypotube kinks.
Event or Problem Description
It was reported that removal difficulties were encountered.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified middle and distal end of right coronary artery.A 3.5mm x 8mm quantum maverick balloon catheter was advanced for dilation.The guidezilla guide extension catheter was lifted up however, it become stuck with the balloon and the balloon shaft was damaged.The device was simply removed nad the procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient's status was stable.It was further reported that there was no device issue for the 3.5mm x 8mm quantum maverick balloon.
Event or Problem Description
It was reported that removal difficulties were encountered.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified middle and distal end of right coronary artery.A 3.5mm x 8mm quantum maverick balloon catheter was advanced for dilation.The guidezilla guide extension catheter was lifted up however, it become stuck with the balloon and the balloon shaft was damaged.The device was simply removed nad the procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient's status was stable.It was further reported that there was no device issue for the 3.5mm x 8mm quantum maverick balloon.

• 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: 10791226
• Report Number: 2134265-2020-15341
• Device Sequence Number: 1047598
• Product Code: LOX
• UDI-Device Identifier: 08714729392583
• UDI-Public: 08714729392583
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2020

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: 10/15/2022
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0024604110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 11/04/2020; 12/08/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 11/23/2020; 12/15/2020
• 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