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

Model Number	7005
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that shaft break occurred.A 3.5mm x 8mm quantum maverick balloon catheter was advanced for dilatation.However, during procedure the delivery shaft was fractured.The procedure was completed with another of the same device.No patient serious injury or adverse event were reported and the patient's status was stable.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.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: 2134265-2018-64397 to: 2134265-2018-63416.
Event or Problem Description
It was reported that shaft break occurred.A 3.5mm x 8mm quantum maverick balloon catheter was advanced for dilatation.However, during procedure the delivery shaft was fractured.The procedure was completed with another of the same device.No patient serious injury or adverse event were reported and the patient's status was stable.Device evaluated by mfr.: the outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the hypotube is separated 72.2cm from the hub.There is a kink 69.5cm from the hub.Microscopic examination revealed that the tip is damaged and appears to be flattened a little.The balloon is still tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the hypotube is separated but appeared to be kinked prior to separation.

• 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: 8126038
• Report Number: 2134265-2018-63416
• Device Sequence Number: 2261516
• Product Code: LOX
• UDI-Device Identifier: 08714729392583
• UDI-Public: 08714729392583
• 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): 01/25/2019

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: 04/05/2021
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0021955802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1