MAUDE Adverse Event Report: CORDIS CORPORATION CATH F5 INF JR 4 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	534521T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review of lot 17808372 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 5f inf jr 4 100cm guiding catheter tip came apart from the probe, detachment of the two parts.There was no reported patient injury.The device separated in two pieces when it was removed from the package.The device was not used in the patient.The device did not separate inside the patient.
Additional Manufacturer Narrative
Complaint conclusion: during removal from the packaging, a 5f inf jr 4 100cm guiding catheter proximal end separated and the device being elongated.There was no reported patient injury.The device was not used in the patient.The device did not separate inside the patient.No other information was reported.The device was returned for analysis.A non-sterile cath f5 inf jr 4 100cm diagnostic catheter was received for analysis coiled inside a plastic bag.Per visual analysis, the body shaft of the catheter was noted to be separated from the strain relief and hub.Also, a kink was noted 39.7 cm from the distal tip.No other anomalies were found.Per dimensional analysis, the outer diameter (od) and inner diameter (id) of the proximal area were measured close to the area where the separation and kink were noted, and results were found within specification.Scanning electron microscopic (sem) analysis was performed in order to identify the root cause of the body separation.The hub was spliced, and evidence of transferred material was noted.Sem results showed that the separated area of the proximal end presented with evidence of elongations, the braid wires separated areas presented with evidence of plastic deformation and ductile dimples.The mentioned evidences are commonly associated with separations caused by material tensile overload.Therefore, it is thought that the body shaft of the catheter was induced to a tensile force that exceeded the braid wires and outer body material yield strength prior to the separation.No other issues were noted during sem analysis.A product history record (phr) review of lot 17808372 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The reported ¿catheter (body/shaft) - separated - during prep¿ was confirmed since the body shaft of the catheter was noted to be separated from the strain relief and hub.Nevertheless, sem analysis results suggest the catheter body shaft was induced to a tensile force that exceeded the braid wires and outer body material yield strength prior to the separation.Also, dimensional results were found within specification.Storage and handling factors likely contributed to the reported event.As per the instructions for use (ifu), which is not intended as a mitigation, ¿precautions: store in a cool, dark, dry place.Do not use if package is open or damaged.Do not use the catheter if the ¿use by¿ date on the package label has expired.Do not resterilize.Exposure to temperatures above 54c (130f) may damage the catheter.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ phr review and product analysis results do not suggest that the reported event could be related to the manufacturing process.Therefore, no actions will be taken.

• Brand Name: CATH F5 INF JR 4 100CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8564784
• Report Number: 9616099-2019-02883
• Device Sequence Number: 2349195
• Product Code: DQO
• UDI-Device Identifier: 20705032013694
• UDI-Public: 20705032013694
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K970854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 534521T
• Device Catalogue Number: 534521T
• Device Lot Number: 17808372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1