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

Model Number 45007

Device Problem Suction Problem (2170)

Patient Problem Embolism (1829)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

Date of birth: (b)(6).Device eval by manufacturer:returned product consisted of a jetstream xc-2.4 atherectomy catheter.The device was visually examined for any shaft damage and the functional testing of the device was completed.The device showed no damage.Functional analysis was completed.Test results showed that this device did not perform as designed withdrawing 1ml of fluid in the 1 minute time frame.Dissection of the catheter shaft showed that the aspiration lumen was occluded with a heavy clot burden which contributed to the aspiration issues.Inspection of the remainder of the device, revealed no damage or irregularities.

Event Description

It was reported that a loss of aspiration occurred and the patient experienced an embolism.Two 2.4mm jetstream xc catheters were selected for an atherectomy procedure in the superficial femoral artery (sfa).The first catheter was activated and initially withdrew fluid; however aspiration just stopped.The second catheter was used to complete the procedure.No performance issues were noted with the second catheter.The patient experienced some emboli downstream into the tibial artery.A manual aspiration device and an angiojet dista device were used to remove the emboli.

• 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: 8607856
• MDR Text Key: 144969509
• Report Number: 2134265-2019-05183
• 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: K130637
• 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: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2020
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0023195795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention