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

Model Number 45007

Device Problems Material Deformation (2976); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/11/2023

Event Type  malfunction  

Event Description

It was reported that there was a buildup of plastic material on the catheter.The target lesion was located in the superficial femoral artery.A 2.1mm jetstream xc atherectomy catheter was selected for the procedure.During preparation, it was noticed that one of the pins appeared to be warped.The pin was straightened, and the jetstream xc atherectomy catheter was used as normal.Then, during the procedure, there was a buildup of plastic material on the middle part of the catheter.The catheter was being used in the patient at the time.The catheter was exchanged for another catheter, and the procedure was completed.There were no patient complications reported.

Event Description

It was reported that there was a buildup of plastic material on the catheter.The target lesion was located in the superficial femoral artery.A 2.1mm jetstream xc atherectomy catheter was selected for the procedure.During preparation, it was noticed that one of the pins appeared to be warped.The pin was straightened, and the jetstream xc atherectomy catheter was used as normal.Then, during the procedure, there was a buildup of plastic material on the middle part of the catheter.The catheter was being used in the patient at the time.The catheter was exchanged for another catheter, and the procedure was completed.There were no patient complications reported.

Manufacturer Narrative

Sections updated in supplemental report: b5- corrected word "wrapped" to "warped".Device evaluation by manufacturer: the device returned to boston scientific consisted of a jetstream xc-2.1 atherectomy catheter.The device was visually examined for any shaft damage.Visual and microscopic examination showed 3 kinks on the shaft located 1cm, 8cm and 9cm from the tip.The device showed a burst infusion sheath on the catheter shaft located 16cm from the tip.A pin in the connector was bent.The device was inserted into the console and set up per the instructions for use (ifu).The device ran as designed; however, the device leaked fluid during functional testing at the burst infusion sheath location.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Device analysis determined the condition of the returned device was consistent with the reported information.The complaint for material separation (deformation) was confirmed.

• Brand Name: JETSTREAM XC ATHERECTOMY CATHETER
• 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: 16257785
• MDR Text Key: 308580414
• Report Number: 2124215-2023-03151
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

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: 0030293614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 01/27/2023
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2022
• 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