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

Model Number	7005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	04/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.During unpacking of a 3.25mmx8mm quantum maverick balloon catheter, it was noticed that the delivery shaft was fractured.No patient complications reported as the device did not enter the patient's body.
Additional Manufacturer Narrative
Lot number corrected to 0020903544.- expiration date corrected to 07/17/2020.Unique identifier (udi)# corrected to (b)(4).Device manufacture date corrected to 7/19/2017.The quantum maverick was returned for analysis.The balloon was tightly folded.The tip, balloon, inner/outer shaft and hypotube were microscopically and visually inspected.Inspection revealed numerous kinks in the hypotube, and a hypotube fracture located 74.2 cm from the tip of the device.The fracture faces of the hypotube were ovalized, as if kinked prior to separating.Inspection of the rest of the device found no damage or defect with the device.
Event or Problem Description
It was reported that shaft break occurred.During unpacking of a 3.25mmx8mm quantum maverick balloon catheter, it was noticed that the delivery shaft was fractured.No patient complications reported as the device did not enter the patient's body.

• 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: 8608559
• Report Number: 2134265-2019-05065
• Device Sequence Number: 2280937
• Product Code: LOX
• UDI-Device Identifier: 08714729392576
• UDI-Public: 08714729392576
• 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): 06/11/2019

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: 07/17/2020
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0020903544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 59