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

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2019

Event Type  malfunction  

Event Description

It was reported that the coating was peeling from the guidewire.An unknown jetstream xc atherectomy catheter was selected for a procedure in an unknown anatomical location.Upon follow-up with a physician from the sales representative, the physician stated the coating peeled off the non-bsc guidewire when an attempt to load the device onto the guidewire was performed.The guidewire was removed, and exchanged for a different non-bsc guidewire.The procedure was completed, and the patient was in stable condition following the procedure.

• Brand Name: JETSTREAM 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9252053
• MDR Text Key: 164694916
• Report Number: 2134265-2019-13080
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130637
• 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: 10/29/2019

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 10/29/2019
• 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