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

Model Number	7010
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.The patient presented with acute myocardial infarction.The 70-80% stenosed target lesion was located in the mildly tortuous and non-calcified mid left anterior descending artery.A 2.5mm x 12mm quantum maverick balloon catheter was selected for post dilatation.However, resistance was felt when the device was advanced through the guide.The device was completely removed and found that the shaft was broke 31 centimeters from the hub.No patient complications were reported.
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6).Device evaluated by mfr.: the device was returned for analysis.Returned product consisted of a quantum maverick balloon catheter in two pieces.The device was bloody and filled with contrast.The balloon was loosely folded.Analysis of the tip, balloon, inner/outer shaft and hypotube included microscopic and visual inspection.Inspection revealed numerous kinks in the hypotube, and a hypotube fracture located 51.1cm from the strain relief, and a kink in the distal shaft located 19.8 cm.The fracture faces were ovalized, suggesting the area was kinked prior to fracturing.Inspection of the rest of the device found no other damage or defects.The guide catheter used in the procedure, with the complaint device was not returned for analysis.Also, due to the complaint device being fractured in the hypotube/shaft, device to device testing with a lab supplied guide catheter could not be done.
Event or Problem Description
It was reported that shaft break occurred.The patient presented with acute myocardial infarction.The 70-80% stenosed target lesion was located in the mildly tortuous and non-calcified mid left anterior descending artery.A 2.5mm x 12mm quantum maverick balloon catheter was selected for post dilatation.However, resistance was felt when the device was advanced through the guide.The device was completely removed and found that the shaft was broke 31 centimeters from the hub.No patient complications were reported.

• 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: 10901851
• Report Number: 2134265-2020-16132
• Device Sequence Number: 2489774
• Product Code: LOX
• UDI-Device Identifier: 08714729392651
• UDI-Public: 08714729392651
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

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: 09/24/2022
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0024488776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR