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

Model Number 45007

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

Device analysis by mfr: the returned product consisted of a jetstream xc 2.4mm atherectomy catheter.The guidewire was returned.Inspection of the device found no damage.Visual and microscopic analysis was completed to verify the black substance.There was no black substance noticed on the tip area.A.014 spiderfx test guidewire was used to insert into the tip to try and recreate the customers reported information.The wire did show evidence of coating being peeled during the insertion into the catheter tip.Product analysis tested the device by connecting it to the jetstream console per directions for use.The device functioned as designed with no issues or errors.Inspection of the remainder of the device, revealed no damage or irregularities.

Event Description

It was reported that the coating peeled off the wire.A 2.4mm jetstream xc catheter was selected for use in an atherectomy procedure in the left superficial femoral artery (sfa).At the start of the procedure, the device was removed from the packaging and prepped following the directions for use.After priming the device in saline, the physician loaded the device on a non-bsc filter wire.As the device was loaded on the filter wire, black wire speckling material was found on the glove of the physician.It was caused by catheter scraping the filter wire.The physician removed the device from the filterwire, re-primed it, and began loading the device over the wire once more.The physician then noticed more black speckling coming off the wire, and on his glove.The device was removed from the wire.A non-bsc device was selected to successfully complete the procedure.There were no patient complications reported.The patient condition was reported as stable post-procedure.

• Brand Name: JETSTREAM XC
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road cork; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9220721
• MDR Text Key: 166570897
• Report Number: 2134265-2019-12736
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: 08714729889922
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2021
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0023338539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2019
• 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 Age: 52 YR