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

Model Number	7005
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.Visual examination revealed multiple kinks along the whole device.The hypotube is separated 27.6cm from the hub and it appears to have been kinked prior to separation.Microscopic examination revealed no additional damages.The balloon was still tightly folded prior to inflation testing.The balloon was inflated to rated burst pressure (rbp) and held pressure for 5 minutes.
Event or Problem Description
Reportable based on device analysis completed on  24-jan-2019.It was reported that failure to inflate was encountered.   the target lesion was located in the left circumflex coronary artery (lcx).A 2.75mm x 8mm quantum maverick balloon catheter was advanced.However, during post dilate, balloon failed to inflate and was removed successfully.The procedure was completed with another balloon.There were no patient complications reported.However, returned device analysis revealed shaft break.

• 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: 8350708
• Report Number: 2134265-2019-01359
• Device Sequence Number: 1954352
• Product Code: LOX
• UDI-Device Identifier: 08714729392552
• UDI-Public: 08714729392552
• Combination Product (Y/N): N
• 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): 02/19/2019

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: 03/31/2020
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0020413757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR