MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE JETSTREAM® XC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 112264-003

Device Problem Entrapment of Device (1212)

Patient Problem Embolism (1829)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as: 2134265-2018-05001.It was reported the device became entrapped on the guidewire and an embolism occurred.A 2.1 mm jetstream® xc atherectomy catheter and a 300 cm 0.014 thruway guidewire were selected for an atherectomy procedure of in-stent restenosis in the left superficial femoral artery (sfa).Two other interventional procedures were performed prior that included angioplasty, drug coated balloons and drug coated stents using unspecified devices.Two passes were made in blades down mode.The catheter became entrapped on the guidewire and with some difficulty, the physician was able to withdraw the wire.The jetstream catheter was in situ with no wire.An attempt was made to reload the wire; however the catheter was unable to be loaded onto the wire.The jetstream was removed from the patient and was still unable to load onto the wire.A new thruway wire was opened and attempted to load through the jetstream catheter; however this wire was unable to load.Some embolization occurred during the case, most of which was resolved at the time.A new jetstream catheter was selected.The second thruway wire was loaded into the new jetstream and the procedure was successfully completed with two passes in blades up mode.The patient was sent back to the ward and was given overnight heparin and the patient was sent home shortly afterwards.The patient was feeling much better and slept well.The patient's condition was stable.The patient was readmitted a week later with a very ischemic leg.An amputation was performed and afterwards the patient went into cardiac arrest and died.

• Brand Name: JETSTREAM® XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7534557
• MDR Text Key: 108938042
• Report Number: 2134265-2018-04423
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K130637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 112264-003
• Device Catalogue Number: PV31300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other