MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN BRITE TIP SI; INTRODUCER, CATHETER

Catalog Number UNKNOWN

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, during the peripheral angioplasty, the powerflex pro pta (6mm15cm 135) balloon catheter did not enter trough the guidewire, there was much resistance; therefore, another balloon was used and worked well.There was no reported patient injury.A 6f vista brite tip catheter sheath introducer was used in the procedure.The device was stored and handled per the instructions for use ifu.There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.There were no kinks noted on the device prior to use.The device was prepped according to instructions for use (ifu).The catheter was flushed with heparinized saline.The insertion difficulty was caused by a blockage of possibly injectable material.There was no excessive force applied on the device while inserting it over the guide wire.Other products were successfully used with the device prior to the encountered resistance.The catheter was not torqued against resistance.There was no unusual force used at any time during the procedure.The difficulty require that only the reported product was removed.The device was removed intact (in one piece) from the patient.The procedure was completed with another balloon.The procedure was completed successfully without patient injury.There are no procedural films available.The device will not be returned for analysis.

Manufacturer Narrative

After further review of additional information received the following sections g4 and h2 have been updated accordingly.This case will be un-reported as based on the additional information received on 29-mar-2019, after further review of additional information received it was noted that there was no allegation that the sheath had any issue with the balloon catheter.This is one of 2 products involved with the reported event and the associated manufacturer report number is 9616099-2019-02880.

• Brand Name: UNKNOWN BRITE TIP SI
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8535565
• MDR Text Key: 145120465
• Report Number: 9616099-2019-02864
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K984500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: POWERFLEXPRO 6MM15CM 135
• Patient Age: 76 YR