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

Model Number 45007

Device Problems Display or Visual Feedback Problem (1184); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis consisted of a jet stream xc 2.1 mm atherectomy catheter.The device was visually examined and it showed a severe kink located 44.5 cm from the tip.It was noticed that the drive coil was broken at this location due to the severe kink on the shaft.With a broken drive coil the tip would not spin as designed.Functional analysis was completed.There were no issues or errors during functional testing of the motor rotation.The devices motor ran for a period of 3 consecutive minutes with no system errors.

Event Description

Reportable based on device analysis completed on 16 aug 2019.It reported that an error message occurred.A 2.1 mm jetstream xc catheter was selected for atherectomy procedure.The device had grd2 message error code.Multiple attempts were completed to try to resolve the error.The procedure was completed with another jetstream xc catheter.There were no patient complications reported and the patient's status was stable.However, device analysis revealed the drive coil was broken and the tip had rotation issues.It was further reported that the device had a saline leak in the body of the catheter.

• 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8932472
• MDR Text Key: 155668379
• Report Number: 2134265-2019-10286
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• Combination Product (y/n): N
• PMA/PMN Number: K133023
• 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: 08/26/2019

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: 02/13/2021
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0023496896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2019
• 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