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

Model Number	7015
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 3.25mm x 15mm quantum maverick balloon catheter was advanced for dilatation.However, the balloon ruptured.No patient complications were reported.
Additional Manufacturer Narrative
This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/18/2018 04:57 pm ct.The report number is being corrected from: 2134265-2018-64133 to: 2134265-2018-63102.
Event or Problem Description
It was reported that balloon rupture occurred.A 3.25mm x 15mm quantum maverick balloon catheter was advanced for dilatation.However, the balloon ruptured.No patient complications were reported.Device evaluated by mfr.: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the whole device.Microscopic examination revealed that the inflation lumen is stretched 25.1cm from the tip and is approximately 11.5cm long.The tip is damaged and the balloon was still tightly folded prior to inflation testing.There is blood present in the guidewire lumen and on the balloon folds.Review of the product specification indicates the rated burst pressure (rbp) of the complaint device.The balloon was inflated to rbp and could hold pressure for 5 minutes.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 8097297
• Report Number: 2134265-2018-63102
• Device Sequence Number: 1903007
• Product Code: LOX
• UDI-Device Identifier: 08714729392798
• UDI-Public: 08714729392798
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/22/2019

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: 05/11/2020
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0020638037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1