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	02/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 85% stenosed, 13x4.0mm target lesion was located in the mildly tortuous and moderately calcified left main coronary artery.A 4.0mm x 12mm quantum maverick balloon catheter was advanced for dilation.However, it was noted that the delivery shaft of the balloon was fractured.There were no fragments left inside the patient.The procedure completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluaed by mfr: returned device consisted of a quantum maverick mr balloon catheter.The balloon was tightly folded.The tip, balloon, markerbands, proximal weld, inner/outer shaft (lumen) were microscopically and visually inspected.Inspection revealed numerous kinks in the hypotube with no separation.Inspection of the remaining device found no other defects or irregularities.
Event or Problem Description
It was reported that shaft break occurred.The 85% stenosed, 13x4.0mm target lesion was located in the mildly tortuous and moderately calcified left main coronary artery.A 4.0mm x 12mm quantum maverick balloon catheter was advanced for dilation.However, it was noted that the delivery shaft of the balloon was fractured.There were no fragments left inside the patient.The procedure completed with another of the same device.No patient complications were reported and the patient's 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: 8417283
• Report Number: 2134265-2019-02352
• Device Sequence Number: 11222542
• Product Code: LOX
• UDI-Device Identifier: 08714729392712
• UDI-Public: 08714729392712
• 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): 04/04/2019

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: 05/17/2021
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 22140264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 54