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

Model Number 45007

Device Problems Mechanical Problem (1384); Difficult to Advance (2920)

Patient Problems Pain (1994); Perforation of Vessels (2135)

Event Date 10/23/2018

Event Type  Injury  

Event Description

(b)(6) study.It was reported that the patient experienced a perforation and pain.The 100% stenosed, 4mmx80mm, tasc ii b target classified lesion was located in the left distal superficial femoral artery.The lesion was treated with a 2.1 mm jetstream xc atherectomy catheter and jetstream console.After the guide wire passed through the lesion and through the true cavity, the jetstream catheter was rotated once; however, due to a malfunction, the device failed.At this time subject experienced pain.Due to the pain, a piperidine injection was injected 50 mg intramuscularly.A second attempt was made to insert the jetstream catheter; however it failed to pass through the lesion.Hence, the catheter was pulled out and flushed in-vitro.A third attempt was made with the same catheter; however the catheter was unable to be pushed forward and during this, a vascular perforation was noted.The location of the perforation was a segment of target lesion detected through angiography.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed followed by stent implantation to stop the bleeding, with 0 % final residual stenosis.Both of the events were considered to be recovered/resolved.

Manufacturer Narrative

This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/12/2018 12:51 pm ct.The report number is being corrected from: 2134265-2018-63898 to: 2134265-2018-62884.

Event Description

Jetstream china study it was reported that the patient experienced a perforation and pain.The 100% stenosed, 4mmx80mm, tasc ii b target classified lesion was located in the left distal superficial femoral artery.The lesion was treated with a 2.1 mm jetstream xc atherectomy catheter and jetstream console.After the guide wire passed through the lesion and through the true cavity, the jetstream catheter was rotated once, however due to a malfunction, the device failed.At this time subject experienced pain.Due to the pain, a piperidine injection was injected 50 mg intramuscularly.A second attempt was made to insert the jetstream catheter, however it failed to pass through the lesion, hence the catheter was pulled out and flushed in-vitro.A third attempt was made with the same catheter, however the catheter was unable to be pushed forward and during this, a vascular perforation was noted.The location of the perforation was a segment of target lesion detected through angiography.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed followed by stent implantation to stop the bleeding, with 0 % final residual stenosis.Both of the events were considered to be recovered/resolved.It was further reported that the patient experienced left leg pain.The vascular perforation was noted in the superficial femoral artery.

Event Description

Jetstream china study it was reported that the patient experienced a perforation and pain.The 100% stenosed, 4mmx80mm, tasc ii b target classified lesion was located in the left distal superficial femoral artery.The lesion was treated with a 2.1 mm jetstream xc atherectomy catheter and jetstream console.After the guide wire passed through the lesion and through the true cavity, the jetstream catheter was rotated once, however due to a malfunction, the device failed.At this time subject experienced pain.Due to the pain, a piperidine injection was injected 50 mg intramuscularly.A second attempt was made to insert the jetstream catheter, however it failed to pass through the lesion, hence the catheter was pulled out and flushed in-vitro.A third attempt was made with the same catheter, however the catheter was unable to be pushed forward and during this, a vascular perforation was noted.The location of the perforation was a segment of target lesion detected through angiography.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed followed by stent implantation to stop the bleeding, with 0 % final residual stenosis.Both of the events were considered to be recovered/resolved.It was further reported that the patient experienced left leg pain.The vascular perforation was noted in the superficial femoral artery.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a jetstream xc-2.1 atherectomy catheter.The shaft, pod and the remainder of the device were inspected for damage.It was noticed that the catheter shaft showed buckling/kinking damage approximately 1cm from the tip.The location of the damage indicate that this was most likely an interaction issue with the introducer sheath.Pushing, pulling and torqueing of the device may have contributed to the damage that was noticed.The device was connected to the jetstream console per the dfu.The device was primed and activated.The device functioned as designed in all modes of blades up and blades down.The advancement issues the customer experienced is consistent with sheath interference.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 01/16/2019 08:22 am ct.The report number is being corrected from: 2134265-2019-00092 to: 2134265-2018-62884.

• 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: 8071378
• MDR Text Key: 127167142
• Report Number: 2134265-2018-62884
• 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,Followup
• Report Date: 01/25/2019

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: 10/14/2019
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0021375755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Manufacturer Received: 10/25/2018
• Initial Date FDA Received: 11/14/2018
• Supplement Dates Manufacturer Received: 01/04/2019; 01/04/2019
• Supplement Dates FDA Received: 01/25/2019; 01/25/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR