MAUDE Adverse Event Report: VASCULAR DANVERS MFG EXPORT AP ASPIRATION CATHETER; CATHETER, EMBOLECTOMY

Model Number UNK-CV-DAN-EXP-AP

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

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Heart Failure (2206); Injury (2348); Blood Loss (2597)

Event Date 06/23/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

6f export aspiration catheters were used to perform manual aspiration thrombectomy in procedures which were part of a study which investigated that women are more likely than men to experience adverse cardiac events after st-elevation myocardial (stemi).The thirty day clinical outcomes included major adverse events - death, myocardial infarction, reinfarction, revascularization, heart failure, stroke and bleeding.

• Brand Name: EXPORT AP ASPIRATION CATHETER
• 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: 8891902
• MDR Text Key: 154248334
• Report Number: 1220452-2019-00097
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120808
• 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: UNK-CV-DAN-EXP-AP
• Device Catalogue Number: UNK-CV-DAN-EXP-AP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2019
• 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): Hospitalization
• Patient Age: 58 YR