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

Model Number	7010
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick 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 fracture in the hypotube located 73.2cm from the tip of the device, and a kink in the hypotube located 77cm from the tip.The fracture faces of the hypotube were ovalized, suggesting the area was kinked prior to becoming separated.Inspection of the rest of the device found no other damage or defects.The reported device kink was confirmed.
Event or Problem Description
Reportable based on device analysis completed on 16dec2020.It was reported that shaft kink occurred.The 93% stenosed, 13mmx2.5mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.5mm x 12mm quantum maverick balloon catheter was advanced for use.However, during procedure, the shaft was kinked at 70cm from the physician's hand.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed a shaft detachment.

• 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: 11055940
• Report Number: 2134265-2020-18332
• Device Sequence Number: 16887648
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2020

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: 11/07/2022
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0024734359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 12/22/2020
• 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: 72