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

Model Number 45007

Device Problems Break (1069); Leak/Splash (1354); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2019

Event Type  malfunction  

Event Description

It was reported that the jetstream filled up with fluid and ruptured.A 2.1mm jetstream catheter was selected for an arthrectomy procedure in the superficial femoral artery (sfa).During the procedure, the catheter was introduced by doralis pedis approach through a 6/7f slender sheath pedal retrograde approach through the anterior tibial.The device was introduced and the plan was to treat the sfa.The device went smooth up to the sfa.The device was turned on and was advancing easily but then would not advance anymore.The rpms were steady in the 70s and audible pitch was good and steady as the physician continued to push.Fluid was building up and a bubble was forming outside the shaft of the catheter at the hub of the sheath.The jetstream filled with fluid and ruptured.The device was removed and the arthrectomy was aborted.There were no patient complications and the patient was fine.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a jetstream xc-2.1 atherectomy catheter.Visual examination showed that there was severe shaft damage in the form of buckling/damage located 1cm from the tip.Visual examination noticed that the infusion line had burst proximal buckling.The location of the burst infusion line was approximately 62.5cm from the tip.The device was set up and functionally tested.The device functioned as designed.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 jetstream filled up with fluid and ruptured.A 2.1mm jetstream catheter was selected for an athrectomy procedure in the superficial femoral artery (sfa).During the procedure, the catheter was introduced by doralis pedis approach through a 6/7f slender sheath pedal retrograde approach through the anterior tibial.The device was introduced and the plan was to treat the sfa.The device went smooth up to the sfa.The device was turned on and was advancing easily but then would not advance anymore.The rpms were steady in the 70s and audible pitch was good and steady as the physician continued to push.Fluid was building up and a bubble was forming outside the shaft of the catheter at the hub of the sheath.The jetstream filled with fluid and ruptured.The device was removed and the athrectomy was aborted.There were no patient complications and the patient was fine.

• 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: 8256940
• MDR Text Key: 133355272
• Report Number: 2134265-2019-00108
• 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: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0020297933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2019
• Date Manufacturer Received: 02/25/2019
• Patient Sequence Number: 1