MAUDE Adverse Event Report: BOSTON SCIENTIFIC JETSTREAM SC-1.6 CATHETER; ATHERECTOMY CATHETER

Model Number 112260-001

Device Problem Occlusion Within Device (1423)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 03/03/2015

Event Type  malfunction  

Event Description

The site reported the following: a patient with a moderately calcified distal popliteal artery lesion presented for an atherectomy procedure.The physician used a jetstream atherectomy set to treat the occluded vessel.During the procedure, the catheter began to stick on the spyderwire guidewire and was not able to be advanced.The physician removed the jetstream catheter and used a second jetstream catheter to successfully complete the procedure.There was no injury/adverse event reported.

Manufacturer Narrative

Quality assurance product analysis reviewed the information that was provided by the site.The jetstream sc-1.6 catheter that was in use during the event was discarded; therefore, no further investigation could be performed.Based on the limited information, we are unable to determine the root cause of the alleged issue.In the event additional information is obtained, a follow-up report will be submitted.

• Brand Name: JETSTREAM SC-1.6 CATHETER
• Type of Device: ATHERECTOMY CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC; minneapolis MN
• Manufacturer Contact: diane eckert ; 9055 evergreen blvd., n.w.; minneapolis, MN 55433 ; 7249408677
• MDR Report Key: 4649030
• MDR Text Key: 5595781
• Report Number: 2183460-2015-00026
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2015

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: 11/01/2015
• Device Model Number: 112260-001
• Device Catalogue Number: JETSTREAM
• Device Lot Number: 162339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2015
• Initial Date FDA Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1