MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 JR 4 100CM; CATHETER, PERCUTANEOUS

Model Number 67008200

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17695511 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 6f.070 judkins right (jr) 4 100cm vistabrite tip guiding catheter (gc) was broken.It was found that the connect part of catheter was leaking during prep.There was no reported patient injury.The packaging remained intact.The product was stored in cath lab according to instructions for use (ifu).There were no anomalies noted when the device was taken out of the package.The device was pulled from the packaging by the hub and no anomalies were noted at this time.The device was prepped following (ifu).There was no difficulty encountered flushing the stent delivery systems (sds).A non-cordis indeflator device was used.There was no difficulty encountered connecting the hub to the indeflator device.There were no anomalies noted during the time the device was prepped.The device was not used in the patient.The device will be returned for analysis.

Manufacturer Narrative

After further review of additional information received the following sections d10, g4, g7, h2,h3 and h6 have been updated accordingly.As reported, the connect part of the 6f.070 judkins right (jr) 4 100cm vista brite tip guiding catheter leaked during prep.There was no reported patient injury.The packaging remained intact.The product was stored in cath lab and prepped according to instructions for use (ifu).There were no anomalies noted when the device was taken out of the package and there were no anomalies noted during the time the device was prepped.The device was pulled from the packaging by the hub and no anomalies were noted at this time.The device was not used in the patient.A non-sterile unit of a vista brite tip guiding catheter (6f.070 jr 4 100cm) was received coiled inside of a clear plastic bag.During the visual inspection a kinked/bent condition was observed at 7, 26, 27 29, 40, 42, 43, 58, 60.5 and 100cm from the distal tip.No other damages or anomalies were identified.Functional analysis was performed to determine if any leaking was noticed on the device.A lab sample syringe with was filled with water and attached to the luer hub of the catheter.The distal tip was clamped to avoid that the water flow out of the device.A positive water pressure was applied to verify if any leakage could be noticed.No leakage was observed during the test.Dimensional analysis was performed to verify the correct guiding catheter inner diameter (id) and outer diameter (od), and measurements were taken near the damages.Dimensional analysis results were found within specification.A product history record (phr) review of lot 17695511 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿luer hub catheters¿ leakage during prep¿ was not confirmed.No leakage was observed during the functional test.However, several kinks were observed on the body of the catheter.The exact cause of the reported event could not be conclusively determined during the analysis.Procedural/handling factors might have contributed to this issue.According to the ifu, which is not intended as a mitigation, ¿store in a cool, dark, dry place.Do not use open or damaged packages.Use prior to the ¿use by¿ date.Do not resterilize.Do not expose to organic solvents.Inspect the guiding catheter before use to verify that its size, shape and condition are suitable for the specific procedure.Inspect the guiding catheter upon removal from packaging to verify that it is undamaged.Warning: do not use a guiding catheter that has been damaged in any way.If damage is detected, replace with an undamaged guiding catheter.Prior to use, flush the guiding catheter lumen with a heparinized saline solution.¿ neither the phr review nor the product analysis suggests that the event reported by the customer could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.Corrected data section b5 (describe event or problem): as reported, the connect part of the 6f.070 judkins right (jr) 4 100cm vistabrite tip guiding catheter (gc) leaked during prep.There was no reported patient injury.The packaging remained intact.The product stored in cath lab according to instructions for use (ifu).There were no anomalies noted when the device was taken out of the package.The device was pulled from the packaging by the hub and no anomalies were noted at this time.The device was prepped following instructions for use (ifu).There was no anomalies noted during the time the device was prepped.The device was not used in the patient.

• Brand Name: 6F .070 JR 4 100CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9516103
• MDR Text Key: 200009424
• Report Number: 9616099-2019-03431
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 20705032020432
• UDI-Public: 20705032020432
• Combination Product (y/n): N
• PMA/PMN Number: K021593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 67008200
• Device Catalogue Number: 67008200
• Device Lot Number: 17695511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Date Manufacturer Received: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 69