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

Model Number	H7493808015450
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The balloon was loosely folded, with blood in the wire lumen and dried contrast in the balloon.The tip of the device and a portion of the balloon were not returned for analysis.The balloon and distal shaft were separated/detached, and the distal portion of the detached device was not returned for analysis.The balloon, inner/outer shaft, proximal bond, and hypotube were microscopically and tactile inspected.Inspection revealed numerous kinks in the hypotube, numerous kinks in the distal shaft, with the distal shaft damaged (stretched) for the entire length, and there was only 6mm of balloon material on the device.The balloon and distal shaft were separated/detached, and the distal portion of the detached device was not returned for analysis.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.  (b)(4).
Event or Problem Description
Reportable based on device analysis completed on 02-aug-2018.It was reported that crossing difficulties were encountered.The target lesion was located in the left anterior descending artery.A 4.5mm x 15mm quantum¿ maverick¿ balloon catheter was advanced but failed to cross the lesion.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed longitudinal balloon tear and shaft detached/separated.

• 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: 7797659
• Report Number: 2134265-2018-07342
• Device Sequence Number: 14007666
• Product Code: LOX
• UDI-Device Identifier: 08714729392835
• UDI-Public: 08714729392835
• 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): 08/02/2018

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: 01/10/2021
• Device Model Number: H7493808015450
• Device Catalogue Number: 38080-1545
• Device Lot Number: 0021598503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1