MAUDE Adverse Event Report: BOSTON SCIENTIFIC FETCH2 ASPIRATION CATHETER; MANUAL ASPIRATION CATHETER

Model Number 109400-001

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2015

Event Type  malfunction  

Event Description

The customer reported the following: a patient presented for angioplasty of the left main coronary bifurcation in which a fetch 2 thrombectomy set was being used.When the catheter was placed onto the guidewire and advanced into the sheath, the physician noticed that the catheter shaft had cracked in multiple places.The device was removed and the physician used a pronto lp catheter to successfully complete the case.No adverse event was reported.

Manufacturer Narrative

(b)(4).Quality assurance product analysis received and examined the returned fetch 2 thrombectomy set.Visual examination confirmed that the catheter was kinked and cracked in various places throughout the catheter length.Functional testing determined that the device had a restricted vacuum as a result of the observed kinks and cracking in the catheter.Product analysis determined that the cracked catheter shaft occurred as a result of the energy that was applied, either all at once or repeatedly over time, to overcome the resistance that was met when attempting to advance the catheter through the sheath.

• Brand Name: FETCH2 ASPIRATION CATHETER
• Type of Device: MANUAL ASPIRATION CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC; minneapolis MN
• Manufacturer Contact: diane eckert ; 9055 evergreen blvd nw; minneapolis, MN 55433 ; 7249408677
• MDR Report Key: 4688363
• MDR Text Key: 5693379
• Report Number: 2183460-2015-00028
• Device Sequence Number: 1
• Product Code: DXE
• 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: 03/16/2015

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: 12/10/2016
• Device Model Number: 109400-001
• Device Catalogue Number: FETCH
• Device Lot Number: 185958
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2015
• Initial Date FDA Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2014
• 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