MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 JR 4 100CM; CATHETER, PERCUTANEOUS

Model Number	67008200
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	07/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 6f.070 judkins right 4 vista brite tip catheter could not cross the blood vessel and was cut off during a percutaneous coronary intervention (pci) procedure.There was no reported patient injury.The device will be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18076562 presented no issues during the manufacturing process that can be related to the reported event.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 information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, h6, and h10.Complaint conclusion: as reported, a 6f.070 judkins right 4 vista brite tip catheter could not cross the blood vessel and was cut off during a percutaneous coronary intervention (pci) procedure.There was no reported patient injury.One non-sterile 6f.070 judkins right 4 vista brite tip guiding catheter was received for analysis.The unit was visually inspected, and no separation was observed.The unit was found kinked at 27.0 cm, 35.0 cm, 41.0 cm, 72.7 cm, and 78.5 cm from the id band.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.A product history record (phr) review of lot 18076562 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The event by the customer as ¿catheter (body/shaft)- tracking difficulty¿ was not confirmed due to the nature of the complaint as these conditions cannot be properly duplicated in a laboratory environment.The complaint reported as ¿catheter (body/shaft)- separated - in-patient¿ was not confirmed since no separation was observed on the received unit.However, multiple kinked body shaft conditions were observed on the unit.Shipping/handling factors are a possible cause of these observed damages.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, ¿inspect the guiding catheter before use to verify that its size, shape, and condition are suitable for the specific procedure.If strong resistance is met during manipulation, discontinue the procedure, and determine the cause of the resistance before proceeding.If the cause of the resistance cannot be determined, 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 JR 4 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 lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15275676
• Report Number: 9616099-2022-05915
• Device Sequence Number: 12381824
• Product Code: DQY
• UDI-Device Identifier: 20705032020432
• UDI-Public: (01)20705032020432(17)241231(10)18076562
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 09/20/2022

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: 12/31/2024
• Device Model Number: 67008200
• Device Catalogue Number: 67008200
• Device Lot Number: 18076562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2022
• 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