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

Model Number	H7493808020250
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned product consisted of a quantum maverick balloon catheter in two pieces.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube shaft was completely separated 100.9cm from the hub.The fracture faces were oval as if kinked prior to separation.There was no evidence of any material or manufacturing deficiencies contributing to the damage.There are numerous hypotube kinks.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.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2018.It was reported that shaft kink occurred.During preparation of a 2.5mm x 20mm quantum maverick balloon catheter, it was noted that the delivery shaft was kinked.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.However, returned device analysis reveals hypotube break.

• 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: 7325192
• Report Number: 2134265-2018-01451
• Device Sequence Number: 13480220
• Product Code: LOX
• UDI-Device Identifier: 08714729392873
• UDI-Public: 08714729392873
• 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): 02/09/2018

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: 01/31/2019
• Device Model Number: H7493808020250
• Device Catalogue Number: 38080-2025
• Device Lot Number: 0018783597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1