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.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• 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
• Reporter Country Code: CH
• PMA/PMN Number: K130637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• 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

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• 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
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2017
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/14/2018 Patient Sequence Number: 1