MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 XB 3.5 100CM; CATHETER, PERCUTANEOUS

Model Number	67005400
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, some burrs were found at the head end of a 6f.070 xb 3.5 100cm infinity diagnostic catheter.No patient injury was reported.The device was not returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18014020 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 or Problem Description
As reported, some burrs were found at the head end of a 6f.070 xb 3.5 100cm infinity diagnostic catheter.No patient injury was reported.The device was later returned for evaluation.
Additional Manufacturer Narrative
This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, some burrs were found at the head end of a 6f.070 xb 3.5 100cm infinity diagnostic catheter.No patient injury was reported.The product was returned for analysis.One non-sterile unit of catheter 6f.070 xb 3.5 100cm was received coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.During the visual inspection, the unit was found kinked/bent on the body/shaft, those kinks were located approximately at 3.5, 26.8, 51.3, 53, 78.7 and 90.5 cm from the distal tip.Compressed/crushed conditions were noted on the body/shaft, located approximately at 5, 54.5, 57.5, 67, 71.5 and 86.8 cm from the distal tip.No other anomalies were noted during analysis.Per dimensional analysis, the catheter inner diameter (id) and outer diameter (od), measurements were taken near the damages found.These measurements were verified against the ppe specification and found to be within specification.A product history record (phr) review of lot 18014020 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿brite tip/distal tip ¿ frayed/split/torn¿ was not confirmed during analysis of the returned device.However, several areas of kink/bento and compressed/crushed conditions were observed along the length of the catheter.The exact cause of those conditions could not be determined, however, handling and or shipping factors may have contributed to the issues, as they were not initially reported in the complaint details.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿do not use if package is open or damaged.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: 6F .070 XB 3.5 100CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami laked FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15098936
• Report Number: 9616099-2022-05844
• Device Sequence Number: 14749363
• Product Code: DQY
• UDI-Device Identifier: 20705032020166
• UDI-Public: 20705032020166
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K021593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2022

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: 03/31/2024
• Device Model Number: 67005400
• Device Catalogue Number: 67005400
• Device Lot Number: 18014020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2022
• Supplement Date Received by Manufacturer: 07/26/2022; 08/20/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 08/18/2022; 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown