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

Model Number	67005400
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a coronary angioplasty a brite tip guiding catheter (xb 3.5 6 fr) was requested by the hemodynamicist.At the time of uncovering it was observed that the distal portion of the catheter was fractured (folded).The device was not used in the patient.There was no reported patient injury.The device was properly stored and opened in sterile field.Another catheter was requested for the procedure.There were no complications.
Additional Manufacturer Narrative
The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 18064999 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Additional information is pending and will be submitted within 30 days of receipt.Please note that this is the initial/final report for this product.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, during a coronary angioplasty a vista brite tip guiding catheter (xb 3.5 6 fr) was requested by the hemodynamicist.At the time of uncovering, it was observed that the distal portion of the catheter was fractured (folded).The device was not used in the patient.There was no reported patient injury.The device was properly stored and opened in the sterile field.Another catheter was requested for the procedure.There were no complications.A non- sterile catheter ¿6f.070 xb 3.5 100cm¿ was received for analysis.The catheter was visually inspected observing several kinked/bent conditions located approximately 10.5, 49, 67, 75, and 78 cm from the distal tip.Inner diameter (id) and outer diameter (od) measurements were taken and found within specification.A product history record (phr) review of lot 18064999 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The failure reported by customer as ¿brite tip/distal tip ¿ catheters ~ cracked - during prep¿ was not confirmed.The catheter did not have a crack to the distal tip however, several kinked/bent conditions on the body/shaft were noted.The exact cause of these damages could not be conclusively determined during the analysis.Shipping, storage and/or handling factors may have contributed to the reported event.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 open or damaged packages.Inspect the guiding catheter before use to verify that its size, shape, and condition are suitable for the specific procedure.¿ 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 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13971291
• Report Number: 9616099-2022-05496
• Device Sequence Number: 14660619
• Product Code: DQY
• UDI-Device Identifier: 20705032020166
• UDI-Public: 20705032020166
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K021593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/27/2022

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: 09/30/2024
• Device Model Number: 67005400
• Device Catalogue Number: 67005400
• Device Lot Number: 18064999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 06/24/2022; 06/24/2022; 06/24/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 04/01/2022; 06/02/2022; 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK CATHETER
• Patient Sex: Unknown