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

Model Number 45007

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 08/23/2018

Event Type  Injury  

Event Description

(b)(6) study.It was reported a dissection occurred.On (b)(6) 2018 - the index procedure was performed to treat a 71% stenosed target lesion with a reference vessel diameter of 5.0 mm, length of 50 mm and classified as a tasc ii, located in the left mid superficial femoral artery (sfa).The target lesion was successfully treated with the use of a jetstream xc 2.1/3.0 mm and a jetstream xc 2.4/3.4 catheter.It was noted that a grade b dissection occurred after using the jetstream catheters prior to ballooning and stenting.Intervention was performed to treat the event.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 0% final residual stenosis.The event was considered to be resolved.

Event Description

Jetstream (b)(6) study.It was reported a dissection occurred.On (b)(6) 2018 - the index procedure was performed to treat a 71% stenosed target lesion with a reference vessel diameter of 5.0 mm, length of 50 mm and classified as a tasc ii, located in the left mid superficial femoral artery (sfa).The target lesion was successfully treated with the use of a jetstream xc 2.1/3.0 mm and a jetstream xc 2.4/3.4 catheter.It was noted that a grade b dissection occurred after using the jetstream catheters prior to ballooning and stenting.Intervention was performed to treat the event.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 0% final residual stenosis.The event was considered to be resolved.It was further reported that an entirely specific stenting procedure was performed to treat the grade b dissection which occurred after the use of the jetstream devices, before further balloon and stenting occurred.The returned product consisted of a jetstream xc-2.1 atherectomy catheter.The device and the catheter shaft were checked for damage.The device showed no damage.Per the customer's statement the device was involved in a dissection of a vessel.Functionality of the device was completed by setting up the device per the dfu and the device functioned as designed with no errors or issues.Inspection of the remainder of the device, revealed no other damage or irregularities.Based on the medical review task conducted for this complaint, the reported clinical event is anticipated per the dfu.

Event Description

Jetstream china study.It was reported a dissection occurred.On aug 2018 - the index procedure was performed to treat a 71% stenosed target lesion with a reference vessel diameter of 5.0 mm, length of 50 mm and classified as a tasc ii, located in the left mid superficial femoral artery (sfa).The target lesion was successfully treated with the use of a jetstream xc 2.1/3.0 mm and a jetstream xc 2.4/3.4 catheter.It was noted that a grade b dissection occurred after using the jetstream catheters prior to ballooning and stenting.Intervention was performed to treat the event.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 0% final residual stenosis.The event was considered to be resolved.It was further reported that an entirely specific stenting procedure was performed to treat the grade b dissection which occurred after the use of the jetstream devices, before further balloon and stenting occurred.

• 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: 7889705
• MDR Text Key: 120734113
• Report Number: 2134265-2018-61124
• 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: 11/21/2018

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?: No
• 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: 11/05/2018
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 09/20/2018; 11/08/2018
• Supplement Dates FDA Received: 09/21/2018; 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention