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

Model Number 45007

Device Problems Display or Visual Feedback Problem (1184); Difficult to Remove (1528)

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

Event Date 08/31/2022

Event Type  malfunction  

Event Description

It was reported that the catheter was difficult to remove.A 2.1mm jetstream xc catheter was selected for use in an atherectomy procedure.The target lesion was located in the leg and was moderately calcified.At the completion of the jetstream therapy, a bubl error occurred.The technician attempted to remove the catheter over the guidewire, however, it was extremely difficult to remove.The catheter was ultimately able to be removed from the guidewire and patient.Angioplasty was performed to complete the procedure.There were no patient complications.

Manufacturer Narrative

Device eval by mfr: the device was visually and microscopically examined for any damage.Visual examination revealed multiple minor buckling along the sheath.The device showed damage to the infusion sheath 14.5cm from the strain relief.Functional testing was performed and during testing the damaged section of the sheath would bulge.Testing was stopped to prevent potentially bursting the sheath.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

Event Description

It was reported that the catheter was difficult to remove.A 2.1mm jetstream xc catheter was selected for use in an atherectomy procedure.The target lesion was located in the leg and was moderately calcified.At the completion of the jetstream therapy, a bubl error occurred.The technician attempted to remove the catheter over the guidewire, however, it was extremely difficult to remove.The catheter was ultimately able to be removed from the guidewire and patient.Angioplasty was performed to complete the procedure.There were no patient complications.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15491205
• MDR Text Key: 301574664
• Report Number: 2124215-2022-36980
• 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: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2024
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0029268015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1