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

Model Number 45007

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/27/2024

Event Type  malfunction  

Event Description

It was reported that the outer infusion line was perforated.A 2.1mm jetstream xc atherectomy catheter was selected for a lower limb atherectomy procedure.The procedure had been completed successfully and the catheter was removed without any issues; however, upon removal they found two perforated sections on the outer infusion line proximal to the tip.There were no patient complications.

Event Description

It was reported that the outer infusion line was perforated.A 2.1mm jetstream xc atherectomy catheter was selected for a lower limb atherectomy procedure.The procedure had been completed successfully and the catheter was removed without any issues; however, upon removal they found two perforated sections on the outer infusion line proximal to the tip.There were no patient complications.

Manufacturer Narrative

Device eval by manufacturer: this 2.1mm jetstream xc atherectomy catheter was returned and analyzed.Visual analysis revealed shaft damage located 1 cm, and the infusion line was burst 9 cm from the tip.The device was set-up per the instructions for use and the device ran; however, the rotation was sporadic due to the damage on the catheter shaft.There was a leak noticed at the infusion line burst location 9 cm from the tip.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Analysis was able to confirm the infusion break reported from the field.

• Brand Name: JETSTREAM XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18979072
• MDR Text Key: 338607826
• Report Number: 2124215-2024-17991
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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 Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0032820372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1