MAUDE Adverse Event Report: CORDIS CORPORATION CATH F6INF TL JR 3.5 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	534619T
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a coronary angiography, the nurse delivered a 6f infiniti angiography catheter (cath f6inf jr 3.5 100cm) to the doctor, and it was found that there was a ¿burr¿ on the tip of the catheter.The catheter was replaced.There was no reported patient injury.The device is not available for evaluation.The hospital reported it as an adverse event to the china nmpa directly.Please upgrade this case to ae.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.
Additional Manufacturer Narrative
As reported, during a coronary angiography, the nurse delivered a 6f infiniti angiography catheter (cath f6inf jr 3.5 100cm) to the doctor, and it was found that there was a ¿burr¿ on the tip of the catheter.The catheter was replaced.There was no reported patient injury.The product was not returned for analysis.A product history record (phr) review of lot 18049212 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer event ¿brite tip/distal tip- frayed/split/torn-during prep¿ could not be confirmed.Handling factors such as removing the catheter from its packaging by the distal tip 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.To prevent damage to the catheter tip during removal from the package, grasp the hub and gently 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: CATH F6INF TL JR 3.5 100CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 14758370
• Report Number: 9616099-2022-05729
• Device Sequence Number: 5050606
• Product Code: DQO
• UDI-Device Identifier: 10705032014175
• UDI-Public: 10705032014175
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K970854
• 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
• Report Date (Section B): 06/21/2022

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: 07/31/2024
• Device Model Number: 534619T
• Device Catalogue Number: 534619T
• Device Lot Number: 18049212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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