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

Model Number	H7493808008450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The 85% stenosed target lesion was located in a coronary artery.During unpacking of a 4.5mm x8mm quantum¿ maverick¿ balloon catheter, it was noted that the device delivery shaft was fractured.The procedure was completed with a different device.No patient complications were reported and patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the returned product consisted of a quantum maverick balloon catheter in two pieces.The balloon was tightly folded.The hub, hypotube, port/exit notch, inner/outer shaft were microscopically and tactile inspected.Inspection revealed numerous kinks in the hypotube and the hypotube was separated at 53 cm from the tip of the device.Inspection of the remainder of the device presented no other damage or irregularities.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.Bsc id: (b)(4), tw: (b)(4).
Event or Problem Description
It was reported that shaft break occurred.The 85% stenosed target lesion was located in a coronary artery.During unpacking of a 4.5mm x8mm quantum¿ maverick¿ balloon catheter, it was noted that the device delivery shaft was fractured.The procedure was completed with a different device.No patient complications were reported and 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: 7204313
• Report Number: 2134265-2018-00044
• Device Sequence Number: 13488768
• Product Code: LOX
• UDI-Device Identifier: 08714729392613
• UDI-Public: 08714729392613
• 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,Followup
• Report Date (Section B): 12/28/2017

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: 05/25/2020
• Device Model Number: H7493808008450
• Device Catalogue Number: 38080-0845
• Device Lot Number: 0020696777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Initial Date Received by Manufacturer: 12/28/2017
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1