MAUDE Adverse Event Report: STRYKER NEUROVASCULAR SYNCHRO2 SOFT WIRE; VASCULAR ACCESS DEVICE

Catalog Number 2601

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Embolism (1829); Device Embedded In Tissue or Plaque (3165)

Event Date 01/08/2016

Event Type  malfunction  

Event Description

During bronchial artery embolization, the stryker 0.014 in x 200 cm synchro2 soft wire broke in the artery leaving a section of the wire in the artery being embolized.Attempts to withdraw the section were unsuccessful.Since the artery was being embolized it did not have a negative affect on the artery or organ.The lot number is b39386; reference number 2601.

• Brand Name: SYNCHRO2 SOFT WIRE
• Type of Device: VASCULAR ACCESS DEVICE
• Manufacturer (Section D): STRYKER NEUROVASCULAR; 47900 bayside parkway; fremont, CA 94538
• MDR Report Key: 5369298
• MDR Text Key: 36033556
• Report Number: 5369298
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 2601
• Device Lot Number: B39386
• Other Device ID Number: 0.014 IN X 200 CM
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23 YR