MAUDE Adverse Event Report: EV3, INC. SPIDERFX 5.0; TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION

Catalog Number SPD-US-050-320

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 06/09/2021

Event Type  malfunction  

Event Description

During intervention portion of a cardiac catheter procedure for a stemi patient, the spiderfx (distal embolic protection) device was used.Difficulty noticed with insertion/deployment of the filter, device removed, flushed and re-prepped.At that time the distal portion of the wire containing the filter broke off, severing the filter from the wire/device.A new spiderfx was opened and used.No harm was done, minimal delay to procedure.A segment of the product is available for inspection.Fda safety report id# (b)(4).

• Brand Name: SPIDERFX 5.0
• Type of Device: TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION
• Manufacturer (Section D): EV3, INC.
• MDR Report Key: 12087855
• MDR Text Key: 259223268
• Report Number: MW5102198
• Device Sequence Number: 1
• Product Code: NFA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/25/2021

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: 11/18/2021
• Device Catalogue Number: SPD-US-050-320
• Device Lot Number: A934945
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR