MAUDE Adverse Event Report: CORDIS US CORP. INFINITI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	534643T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the catheter tip of a 6f infiniti catheter amplatz right (ar) 2 100 cm was torn during withdrawal of the catheter.The distal tip became separated from the catheter during use and was noted upon removal from the patient.The damage was reported as separated and frayed/split /torn.The torn tip was secured by a loop (there was a kink at the tip that resulted from the loop).There was no reported patient injury.The intended procedure was reported to be a percutaneous transluminal angioplasty (pta).The access site was radial, and the target lesion was in the right coronary.Lesion calcification and vessel tortuosity was mild with less than twenty-five percent (25%) stenosis.The device was not used for a chronic total occlusion (cto).There was no device damage noticed prior to opening the package.The product was stored, handled, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.The patient was not hospitalized or required extended hospitalization because of this event.The device was returned for analysis.
Additional Manufacturer Narrative
The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, the catheter tip of a 6f infiniti amplatz right (ar) 2 100 cm catheter was torn during withdrawal.The distal tip became separated from the catheter during use and was noted upon removal from the patient.The damage was reported as separated and frayed/split /torn.The torn tip was secured by a loop (there was a kink at the tip that resulted from the loop).There was no reported patient injury.The intended procedure was reported to be a percutaneous transluminal angioplasty (pta).The access site was radial, and the target lesion was in the right coronary.Lesion calcification and vessel tortuosity was mild with less than twenty-five percent (25%) stenosis.The device was not used for a chronic total occlusion (cto).There was no device damage noticed prior to opening the package.The product was stored, handled, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.The patient was not hospitalized and extended hospitalization was not required because of this event.A non-sterile unit of cath f6inf tl ar ii mod 100cm was received for evaluation.During visual inspection, a separation was noted 9 cm from the distal tip.No other damages or anomalies were observed during visual analysis.Sem analysis was not performed because the damages associated with the separation are visible with the magnification obtained with a vision system.The damaged area was inspected with a vision system, which presented evidence of elongations.The complaints reported by the customer as ¿brite tip/distal tip - frayed/split/torn¿ and ¿brite tip/distal tip -separated¿ were not confirmed, since these conditions were not found on the catheter tip.However, the malfunction ¿catheter (body/shaft)-separated¿ was confirmed.A separation was found on the body of the catheter.The elongations found on the material are commonly associated with separations caused by material tensile overload.Therefore, it is assumed the device was induced to a tensile force that exceeded the material yield strength prior to the separation.Withdrawing the catheter against resistance is a possible cause of 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, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.¿ 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.
Additional Manufacturer Narrative
After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.

• Brand Name: INFINITI
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18072532
• Report Number: 9616099-2023-06624
• Device Sequence Number: 15407722
• Product Code: DQO
• UDI-Device Identifier: 10705032014311
• UDI-Public: (01)10705032014311(17)260531(10)18218403
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 08/14/2024

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: 05/31/2026
• Device Catalogue Number: 534643T
• Device Lot Number: 18218403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 12/06/2023; 08/14/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 12/13/2023; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2023
• 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 Age: 68 YR
• Patient Sex: Male