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

Model Number	534552S
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the tip end of a 5f 110cm angled pigtail 6 side holes (sh) infiniti diagnostic catheter was found fracture.The percutaneous coronary intervention (pci) procedure was completed with another infiniti catheter.There was no reported patient injury.The patient was reported to have a history of coronary artery disease and had been admitted to the hospital because of pain in the precordial region.Angiography revealed more than eighty per-cent stenosis of the anterior descending branch of the left coronary, requiring pci.The target lesion was reported to be in the bifurcation.There was no lesion calcification or vessel tortuosity.The device was not used for a chronic total occlusion.The access site was radial.There were no anomalies noted when the product was removed from the package.The product was stored, handled, inspected and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.There was no resistance met while advancing the device and no resistance/friction experienced during any part of the procedure.No unusual force was necessary during use of the device and there was no excessive torqueing required.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17961139 presented no issues during the manufacturing process that could be related to the event reported.The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
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 tip end of a 5f 110cm angled pigtail 6 side holes (sh) infiniti diagnostic catheter was found fracture.The percutaneous coronary intervention (pci) procedure was completed with another infiniti catheter.There was no reported patient injury.The patient was reported to have a history of coronary artery disease and had been admitted to the hospital because of pain in the precordial region.Angiography revealed more than eighty per-cent stenosis of the anterior descending branch of the left coronary, requiring pci.The target lesion was reported to be in the bifurcation.There was no lesion calcification or vessel tortuosity.The device was not used for a chronic total occlusion.The access site was radial.There were no anomalies noted when the product was removed from the package.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.There was no resistance met while advancing the device and no resistance/friction experienced during any part of the procedure.No unusual force was necessary during use of the device and there was no excessive torqueing required.The device was returned for analysis.One non-sterile unit of a diagnostic catheter (cath f5 inf pig145 110cm 6sh) was received inside of a clear plastic bag.During the visual inspection, two kinks were found on the body of the catheter at 49 and 66 cm from the distal tips, in addition, the six holes were present in the catheter.No other anomalies were observed.The inner and outer diameter dimensional analysis was performed and was found to be within specification.The fusion area in the catheter was observed under the vision system and no anomalies were found.The product history record (phr) review for lot 17961139 was reviewed and no issues were noted that could be related to the reported complaint.The reported ¿brite tip/distal tip- cracked¿ was not confirmed during analysis of the device, as the catheter was intact with two kinks present on the body.While a definitive cause for the event cannot be determined there are handling factors that can contribute to kinking of the catheter.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, ¿to prevent damage to the catheter during removal from the package, grasp the hub and withdraw the catheter.Based on the information available, product analysis 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: 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 ; 14201 nw 60th avenue; miami lakes, florida 33014 ; 7863138372
• MDR Report Key: 16868385
• Report Number: 9616099-2023-06482
• Device Sequence Number: 20198754
• Product Code: DQO
• UDI-Device Identifier: 10705032013925
• UDI-Public: (01)10705032013925(17)230630(10)17961139
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2023

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: 06/30/2023
• Device Model Number: 534552S
• Device Catalogue Number: 534552S
• Device Lot Number: 17961139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/10/2023
• Supplement Date Received by Manufacturer: 05/09/2023; 06/22/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 05/18/2023; 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK CATHETER
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic