MAUDE Adverse Event Report: CROSPON LTD UNKNOWN ENDOFLIP CATHETER

Model Number UNKNOWN ENDOFLIP CATHETER

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the screen showed 51 degrees and the next step stopped.The catheter was used in patient.The patient was prepped for the procedure and was under anesthesia.A repeat procedure was needed.There was no reported patient outcome.

• Brand Name: UNKNOWN ENDOFLIP CATHETER
• Manufacturer (Section D): CROSPON LTD; galway business park, dangan; galway,fl H91P2 DK
• Manufacturer (Section G): CROSPON LTD; galway business park, dangan; galway,fl H91P2 DK
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 2034925563
• MDR Report Key: 8708377
• MDR Text Key: 191920743
• Report Number: 3006897778-2019-00009
• Device Sequence Number: 1
• Product Code: FFX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN ENDOFLIP CATHETER
• Device Catalogue Number: UNKNOWN ENDOFLIP CATHETER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2019
• 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