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

Model Number 45007

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: older than 18 years.Patient's year of birth reported as (b)(6).Device evaluated by mfr: visual analysis of the returned device revealed damage at the tip area of the device and the tip was pulled away from the catheter shaft.The infusion line appeared to be buckled.There were also some very small buckling/kinked areas located from 17cm proximally all the way to the tip.The observed damage was consistent with damage seen while pushing, pulling and torqueing of the device in a tortuous anatomy or a heavily calcified lesion.Functional analysis revealed the device primed and ran as designed.There was no evidence of a manufacturing issue.Inspection of the remainder of the device, revealed no other damage or irregularities.

Event Description

Reportable based on analysis completed 03-may-2019.It was reported that the device could not advance.A 2.4mm jetstream xc catheter was selected for use.During procedure the device was advancing, however, there was difficulty in the bifurcation and the catheter would not turn.The catheter was then removed and the procedure was completed using a non-bsc device.There were no patient complications reported.However, analysis revealed the tip was separated from the catheter shaft.

• Brand Name: JETSTREAM XC
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road,; cork ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8632318
• MDR Text Key: 145784818
• Report Number: 2134265-2019-05584
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: 08714729889922
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2020
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0022256569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2019
• Initial Date FDA Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1