MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 JL3.5 100CM; CATHETER, PERCUTANEOUS

Model Number	67000200
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This 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.
Event or Problem Description
During prep, when a 6f.070 jl3.5 100cm vista brite tip guiding catheter was used and it was found that the head end was damaged (frayed/split).It was then replaced with another guide catheter (unknown) to complete the operation.There was no reported patient injury.The patient had a history of coronary heart disease and pericardial pain and was admitted to the hospital.Angiographic examination showed that more than eighty percent (80%) of the left anterior descending coronary artery was stenosis, along with seventy percent (70%) calcification and needed percutaneous coronary intervention (pci) treatment.There were no damages noted to the device packaging.There were no difficulties removing the product from the packaging.The brite tip was prepped in accordance with the instruction for use (ifu).There were no excessive force used anytime during the procedure.The device will be returned for evaluation.No other information was provided.
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: during prep, when a 6f.070 jl3.5 100cm vista brite tip guiding catheter was used and it was found that the head end was damaged (frayed/split).It was then replaced with another guide catheter (unknown) to complete the operation.There was no reported patient injury.The patient had a history of coronary heart disease and pericardial pain and was admitted to the hospital.Angiographic examination showed that more than eighty percent (80%) of the left anterior descending coronary artery was stenosis, along with seventy percent (70%) calcification and needed percutaneous coronary intervention (pci) treatment.There were no damages noted to the device packaging.There were no difficulties removing the product from the packaging.The brite tip was prepped in accordance with the instruction for use (ifu).There was no excessive force used anytime during the procedure.No other information was provided.A non-sterile unit of a vista brite tip guiding catheter (6f.070 jl3.5 100cm) was received for analysis.During the inspection a kink/bent condition was found at 23, 50, 51, 79 and 95 cm from the distal tip.No other damages or anomalies were observed on the returned device.Dimensional analysis was performed to verify the correct catheter inner diameter (id) and outer diameter (od.Measurements were taken near the damages and dimensional analysis results were found within specification.A product history record (phr) review of lot 17971483 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The event reported by the customer as ¿brite tip/distal tip- frayed/split/torn - during prep¿ was not confirmed.No damageds were observed at the brite tip area.However, a kink/bent condition was found at the body of the catheter.Shipping/handling factors may have contributed to the reported event.According to the instructions for use (ifu), which is not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use open or damaged packages.Do not resterilize.Do not expose to organic solvents.Inspect the guiding catheter before use to verify that its size, shape, and condition are suitable for the specific procedure.¿ the recommended procedure section in the ifu states, ¿remove the guiding catheter from its packaging.Inspect the guiding catheter upon removal from packaging to verify that it is undamaged.Warning: do not use a guiding catheter that has been damaged in any way.If damage is detected, replace with an undamaged guiding catheter.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: 6F .070 JL3.5 100CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 11995714
• Report Number: 9616099-2021-04638
• Device Sequence Number: 11563568
• Product Code: DQY
• UDI-Device Identifier: 20705032019863
• UDI-Public: 20705032019863
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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: 08/31/2023
• Device Model Number: 67000200
• Device Catalogue Number: 67000200
• Device Lot Number: 17971483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 07/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 76