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

Model Number	H7493808020300
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr.: the device was not returned for analysis.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a coronary artery.A 3.0mm x 20mm quantum¿ maverick¿ balloon catheter was advanced for post-dilatation.The balloon was initially inflated at 12 atmospheres; however, during the second inflation at 18 atmospheres for 20 seconds, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with a non-bsc balloon catheter.No patient complications nor injuries were reported.

• 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: 7227786
• Report Number: 2134265-2018-00743
• Device Sequence Number: 19128958
• Product Code: LOX
• UDI-Device Identifier: 08714729392897
• UDI-Public: 08714729392897
• 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): 01/19/2018

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: 12/31/2017
• Device Model Number: H7493808020300
• Device Catalogue Number: 38080-2030
• Device Lot Number: 0017510826
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1