MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE QUANTUM¿ MAVERICK¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H7493808008270
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 2.75mm x 8mm quantum¿ maverick¿ balloon catheter was advanced for dilatation.However, during advancing, it was noted that the delivery shaft was fractured.The procedure was completed with a different 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 - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6430515
• Report Number: 2134265-2017-02419
• Device Sequence Number: 13462273
• Product Code: LOX
• UDI-Device Identifier: 08714729392552
• UDI-Public: (01)08714729392552(17)20190731(10)19538314
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 03/07/2017

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: 07/31/2019
• Device Model Number: H7493808008270
• Device Catalogue Number: 38080-0827
• Device Lot Number: 19538314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2017
• Initial Report FDA Received Date: 03/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1