MAUDE Adverse Event Report: PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Catalog Number RCF-14.0-38-J

Device Problems Bent (1059); Break (1069); Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 04/01/2015

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

It was reported that prior to patient contact, due to dilator tip damage (bent/deformed/material broken off), the dilator would not fit through the introducer.

• Brand Name: PERFORMER INTRODUCER
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6936160
• MDR Text Key: 90300107
• Report Number: 1820334-2017-03383
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: AY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RCF-14.0-38-J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1