MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 XB 3 100CM; CATHETER, PERCUTANEOUS

Catalog Number 67005200

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot (17527370) presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, ¿the lumen of the 6f guide catheter (.070 xb 3 100 cm) was stenosis¿.There was no reported patient injury.Additional information received indicates that the lumen of the catheter was stenosis.The catheter was not obstructed.There was no obstruction caused by injected material into the patient.The procedure was not for a clot removal.The catheter was flushed with heparinized saline.The patient was heparinized.The device was stored and handled per the instructions for use (ifu).There were no visible signs of device/package damage prior to use.There were no kinks noted on the device prior to use.The device was prepped according to instructions for use (ifu).The difficulty require that all concomitant products be removed together.There was no patient injury.The product will be returned for analysis.

Manufacturer Narrative

After further review of additional information received the sections have been updated accordingly.As per device evaluation the complaint reported by the customer as ¿catheter (body/shaft) ¿ obstructed¿ was not confirmed.There was not obstruction since the water flowed through the guide catheter, also the guidewire insertion - withdrawal test was performance successfully and the dimensional analysis results were found within specification.However, a kinked/bent condition was detected; therefore, the reported case becomes a non-reportable event as the cause of the obstruction cannot be injected into the patient.No additional information will be forthcoming.

• Brand Name: 6F .070 XB 3 100CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7146610
• MDR Text Key: 96128429
• Report Number: 9616099-2017-01732
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K021593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 67005200
• Device Lot Number: 17527370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 01/02/2018
• Supplement Dates FDA Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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