MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM XC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 45007

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

Device eval by manufacturer?: the device was visually and microscopically inspected for damage.There was a kink on the shaft located 67.5cm from the tip and a leak was observed at this location on from the infusion line.The device set up was performed using the instructions per the directions for use.The device primed as designed.The device was run for a period of two consecutive minutes with no issues or errors.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

Event Description

Reportable based on device analysis completed on 07may2020.A 2.1mm jetstream xc catheter was selected for use in a fistula case.During priming, the console reported an error with the catheter.The catheter was flushed and the error remained.A second catheter was selected and used successfully.No patient complications were reported.However, device analysis revealed a leak on the catheter shaft.

• Brand Name: JETSTREAM XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10066955
• MDR Text Key: 191317247
• Report Number: 2134265-2020-06376
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K130637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2021
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0023763545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1