MAUDE Adverse Event Report: VASCULAR DANVERS MFG GUARDWIRE TEMPORARY OCCLUSION SYSTEM; CATHETER, EMBOLECTOMY

Model Number GEZUNK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Stroke/CVA (1770); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Transient Ischemic Attack (2109)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Guardwire distal embolic protection devices were used in carotid artery stenting procedures.The lesions were pre dilated and post dilated in most cases using a non medtronic device.Technical success was achieved in all lesions.Perioperative adverse events including minor stroke, myocardial infarction, transient ischemic attack, perioperative hypotension, perioperative bradycardia, sustained hypotension, puncture site hematoma and acute exacerbation of chronic kidney dysfunction occurred.

• Brand Name: GUARDWIRE TEMPORARY OCCLUSION SYSTEM
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): VASCULAR DANVERS MFG; danvers
• Manufacturer (Section G): VASCULAR DANVERS MFG; danvers
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8891821
• MDR Text Key: 154233692
• Report Number: 1220452-2019-00096
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K023878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GEZUNK
• Device Catalogue Number: GEZUNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/14/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 72 YR