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

Model Number 45007

Device Problems Break (1069); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2019

Event Type  malfunction  

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.Visual examination notice that there were multiple buckling/kinks.The location of the damage was 18cm to 70cm from the tip.The damage was in multiple areas along the location.Visual examination noticed that the infusion line had burst proximal the buckling/kinks.The location of the burst infusion line was approximately 70.5cm to 75.5cm from the tip.The damage that was notice is consistent with sheath interference during the procedure or by pushing, pulling and torqueing of the device in a tortuous anatomy or a heavily calcified lesion.The device was set-up and functionally tested per the dfu and the device functioned as designed except for the leaking at the burst infusion line.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 infusion line bubbled and popped.A 2.1mm jetstream atherectomy catheter was selected for an atherectomy procedure in the left distal superficial femoral artery (sfa) at the adductor canal.The catheter was prepped per usual and used in blades down mode for the entire procedure.During the procedure, the catheter was slowly advanced over a 0.014 thruway guidewire through the occlusion.The catheter advanced until the adductor canal, where it became difficult to advance.As the physician attempted to advance the device, the infusion line of the catheter began to bubble at the entrance to the sheath.A large bubble formed and popped.The catheter was immediately removed from the patient in normal fashion.The procedure was completed with follow up angioplasty and two additional stents placed in the sfa.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.Visual examination notice that there were multiple buckling/kinks.The location of the damage was 18cm to 70cm from the tip.The damage was in multiple areas along the location.Visual examination noticed that the infusion line had burst proximal the buckling/kinks.The location of the burst infusion line was approximately 70.5cm to 75.5cm from the tip.The damage that was notice is consistent with sheath interference during the procedure or by pushing, pulling and torqueing of the device in a tortuous anatomy or a heavily calcified lesion.The device was set-up and functionally tested per the dfu and the device functioned as designed except for the leaking at the burst infusion line.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 infusion line bubbled and popped.A 2.1mm jetstream atherectomy catheter was selected for an atherectomy procedure in the left distal superficial femoral artery (sfa) at the adductor canal.The catheter was prepped per usual and used in blades down mode for the entire procedure.During the procedure, the catheter was slowly advanced over a 0.014 thruway guidewire through the occlusion.The catheter advanced until the adductor canal, where it became difficult to advance.As the physician attempted to advance the device, the infusion line of the catheter began to bubble at the entrance to the sheath.A large bubble formed and popped.The catheter was immediately removed from the patient in normal fashion.The procedure was completed with follow up angioplasty and two additional stents placed in the sfa.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
• MDR Report Key: 8925259
• MDR Text Key: 155354886
• Report Number: 2134265-2019-10145
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• Combination Product (y/n): N
• PMA/PMN Number: K133023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

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: 12/24/2020
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0023237806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/23/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 0.014 THRUWAY GUIDEWIRE; 0.014 THRUWAY GUIDEWIRE; 0.014 THRUWAY GUIDEWIRE