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

Model Number 45007

Device Problem Mechanical Problem (1384)

Patient Problem Thromboembolism (2654)

Event Date 02/27/2019

Event Type  Injury  

Event Description

It was reported that the patient experienced an embolism.A femoral / popliteal bypass was occluded with fresh thrombus.An anastomotic stricture was present.A 2.1mm jetstream xc catheter was selected for an atherectomy procedure in the junction of the superficial femoral artery and the saphenous vein bypass.A non-bsc 7fr guiding sheath was placed up and over the bifurcation.A non-bsc embolic protection system and a non-bsc 315cm filter delivery wire were placed just distal to the thrombus.Run off was taken showing patent tibial vessels.The jetstream catheter was then introduced and a few attempts were made to run it through the anastomotic lesion for approximately 2 minutes.Once past the anastomosis, the catheter continued to stall and would not progress.The catheter was removed and an unspecified drug coated balloon was placed to balloon the bypass vein.During use with the jetstream catheter, a large piece of thrombus dislodged which sat on the top of the filter po marker.Multiple attempts to aspirate the clot was performed using export.The thrombus was stented against the vessel wall using promus premier.The filter was then removed; however further clot was dislodged into the proximal peroneal.

Manufacturer Narrative

Age at time of event: approximately 75 years old.

Event Description

It was reported that the patient experienced an embolism.A femoral / popliteal bypass was occluded with fresh thrombus.An anastomotic stricture was present.A 2.1mm jetstream xc catheter was selected for an atherectomy procedure in the junction of the superficial femoral artery and the saphaneous vein bypass.A non-bsc 7fr guiding sheath was placed up and over the bifurcation.A non-bsc embolic protection system and a non-bsc 315cm filter delivery wire were placed just distal to the thrombus.Run off was taken showing patent tibial vessels.The jetstream catheter was then introduced and a few attempts were made to run it through the anastomotic lesion for approximately 2 minutes.Once past the anastomosis, the catheter continued to stall and would not progress.The catheter was removed and an unspecified drug coated balloon was placed to balloon the bypass vein.During use with the jetstream catheter, a large piece of thrombus dislodged which sat on the top of the filter po marker.Multiple attempts to aspirate the clot was performed using export.The thrombus was stented against the vessel wall using promus premier.The filter was then removed; however further clot was dislodged into the proximal perioneal.It was further reported that the jetstream jammed, stopped and would not rotate.No error message displayed.No visible defects were noted.The patient required lytic post procedure and subsequent heparin infusion.The patient's status post procedure was stable.

• 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
• MDR Report Key: 8391161
• MDR Text Key: 137850445
• Report Number: 2134265-2019-01950
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K130637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2020
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0022712465
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 03/10/2019
• Supplement Dates FDA Received: 03/29/2019
• Patient Sequence Number: 1
• Treatment: EMBOLIC PROTECTION SYSTEM: ABBOTT NAV 6; EMBOLIC PROTECTION SYSTEM: ABBOTT NAV 6; FILTER DELIVERY WIRE: BAREWIRE 315CM; FILTER DELIVERY WIRE: BAREWIRE 315CM; GUIDING SHEATH: 7FR TERUMO; GUIDING SHEATH: 7FR TERUMO; EMBOLIC PROTECTION SYSTEM: ABBOTT NAV 6; FILTER DELIVERY WIRE: BAREWIRE 315CM; GUIDING SHEATH: 7FR TERUMO
• Patient Outcome(s): Required Intervention