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

Model Number 45007

Device Problem Suction Problem (2170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2022

Event Type  malfunction  

Event Description

It was reported that a loss of aspiration occurred.The target lesion was located in the tibial artery.A 2.1mm jetstream was selected for use.During the procedure, a loss of performance and aspiration occurred in blades down mode.There were no error messages or resistance noted.Another of the same device was used to complete the procedure.There were no patient complications.

Event Description

It was reported that a loss of aspiration occurred.The target lesion was located in the tibial artery.A 2.1mm jetstream was selected for use.During the procedure, a loss of performance and aspiration occurred in blades down mode.There were no error messages or resistance noted.Another of the same device was used to complete the procedure.There were no patient complications.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a jetstream xc-2.1 atherectomy catheter.The device was visually examined for any shaft damage and the functional testing of the device was completed.The device showed shaft damage in the form of a severe kink located 37.3cm from the tip.There was also a small kink located 76.5cm from the tip.Multiple small bends were also noticed on the shaft.Functional analysis was done by completing the setup procedure per the instructions for use (ifu).The devices blades did not rotate.Aspiration testing of the device was done per the test procedure.The device is tested by using a 100ml beaker of water.The devices tip is submerged in a beaker of fluid and the device is run for a period of 1 minute.The final milliliters of fluid that the beaker shows after the 1minute run time is subtracted from the starting milliliters and the final number is the total that was aspirated (100ml-3ml=97ml).Test results showed that this device did not perform as designed per the test procedure specification sheet withdrawing 3ml of fluid in the 1minute time frame.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

• 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 CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13552632
• MDR Text Key: 285936866
• Report Number: 2134265-2022-01679
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2022

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: 09/19/2023
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0028227133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 04/19/2022
• Supplement Dates FDA Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: 6 SPIDER; GUIDEWIRE: 6 SPIDER