MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA SYSTEM CONSOLE; CATHETER, CORONARY, ATHERECTOMY

Model Number 45038

Device Problems Break (1069); Defective Device (2588); Power Problem (3010)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 08/22/2018

Event Type  malfunction  

Event Description

It was reported that the angiojet ultra system console failed the electrical safety test while conducting the annual preventative maintenance schedule.The angiojet ultra system console was plugged into the fluke safety tester for conducting annual preventative maintenance.The angiojet ultra system was not turned on.During the electrical safety test, the circuit breaker trips at the touch current failing the electrical safety test.No patient involved.

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 12/14/2018 10:47 am ct.The report number is being corrected from: 2134265-2018-64113to: 2134265-2018-61096.This report is follow-up # 1.

Event Description

It was reported that the angiojet ultra system console failed the electrical safety test while conducting the annual preventative maintenance schedule.The angiojet ultra system console was plugged into the fluke safety tester for conducting annual preventative maintenance.The angiojet ultra system was not turned on.During the electrical safety test, the circuit breaker trips at the touch current failing the electrical safety test.No patient involved.The product was not returned for analysis.The device was inspected on site.It was noted that the rear metal plate of the angiojet ultra system had screws off and had to be attached to get correct earth reading.The electrical safety testing was repeated using the fluke meter and angiojet ultra system passed the testing.

Event Description

It was reported to boston scientific corporation on august 16, 2018 that a flexiva 200 laser fiber was used during a stone extraction procedure in the ureter performed on (b)(6) 2018.Reportedly, the laser unit used was lumenis 20 watt console.According to the complainant, during the procedure, it was noted that the laser body broke upon connecting to the laser unit.The procedure was completed with another flexiva 200 laser fiber.There were no serious injury nor adverse patient effects reported as a result of this event.

Manufacturer Narrative

Problem code 1069 captures the reportable event of fiber broke.Investigation results the fiber was returned broken into three pieces.The first piece measured approximately 32.8 cm from the top of the connector to the break.The second piece measured approximately 141 cm from break to break.The third piece measured approximately 141.8 which includes the entire distal tip.The condition of the returned device confirmed that the fiber was broken.Review and analysis of all available information indicated that the root cause is manufacturing deficiency.An investigation was completed to address this issue which identified the most probable root cause of the fiber break as handling during the manufacturing process caused by the supplier manufacturer.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 12/20/2018 07:47 am ct.The report number is being corrected from: 3005099803-2018-62073 to: 2134265-2018-61096.

• Brand Name: ANGIOJET ULTRA SYSTEM CONSOLE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311 1242
• MDR Report Key: 7885886
• MDR Text Key: 120574755
• Report Number: 2134265-2018-61096
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• PMA/PMN Number: P980037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2019

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
• Device Operator: Other
• Device Model Number: 45038
• Device Catalogue Number: 45038
• Device Lot Number: OEMTRACE
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/28/2018
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/18/2018
• Supplement Dates Manufacturer Received: 12/11/2018; 11/29/2018
• Supplement Dates FDA Received: 01/23/2019; 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1