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

Model Number	7015
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at the time of event: 18 years or older.
Event or Problem Description
It was reported that shaft break occurred.The 98% stenosed, 20mmx2.75mm target lesion was located in the severely tortuous and severely calcified right cronary artery.A 3.0mm x 15mm quantum maverick balloon was advanced for dilatation.However, the shaft was kinked and upon removal, the shaft was fractured outside the patient's body.The procedure was completed with a different device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Age at the time of event: 18 years or older.Device evaluated by mfr.: the device was returned for analysis.Returned product consisted of a quantum maverick mr balloon catheter, in two pieces.The balloon was tightly folded.Analysis of the tip, balloon, inner/outer shaft and hypotube included microscopic and visual inspection.Inspection revealed a complete separation in the hypotube that was located 68.2cm from the strain relief, and there were numerous kinks in the hypotube.Inspection of the rest of the device found no other damage or defects.
Event or Problem Description
It was reported that shaft break occurred.The 98% stenosed, 20mmx2.75mm target lesion was located in the severely tortuous and severely calcified right cronary artery.A 3.0mm x 15mm quantum maverick balloon was advanced for dilatation.However, the shaft was kinked and upon removal, the shaft was fractured outside the patient's body.The procedure was completed with a different device.There were no patient complications reported and the patient 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: 10969209
• Report Number: 2134265-2020-17168
• Device Sequence Number: 11815753
• Product Code: LOX
• UDI-Device Identifier: 08714729392781
• UDI-Public: 08714729392781
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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: 01/01/2023
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0024978952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1