MAUDE Adverse Event Report: CORDIS US. CORP VISTA BRITE TIP; CATHETER, PERCUTANEOUS

Catalog Number	67005200
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18184724 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.
Event or Problem Description
As reported, the brite tip of a 6f.070 xb 3 100 cm vista brite tip guiding catheter was found to be frayed during prep.The device was not used inside the patient.It was replaced with another unknown guiding catheter to complete the procedure.This incident had no effect on the patient.The device was not pulled from the packaging by the hub.The device was not torqued or ¿steered¿ by the hub.The device damage was not frayed into two separate pieces.The target site vessel characteristics were mild calcification, no tortuosity, 80% stenosis, no acute angle and yes bifurcating.The access site was the radial artery, and the characteristics were no calcium, tortuosity, stenosis, acute angle or bifurcating.Angiography revealed more than 80% stenosis of the left anterior descending coronary branch, which required percutaneous coronary intervention (pci).A contralateral approach was not used.The operator had been trained.The patient has a history of coronary artery disease who was admitted to the hospital with anterior cardiac pain.The patient has no infectious diseases.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the brite tip of a 6f.070 xb 3 100 cm vista brite tip guiding catheter was found to be frayed during prep.The device was not used inside the patient.It was replaced with another unknown guiding catheter to complete the procedure.This incident had no effect on the patient.The device was not pulled from the packaging by the hub.The device was not torqued or ¿steered¿ by the hub.The device damage was not frayed into two separate pieces.The target site vessel characteristics were mild calcification, no tortuosity, 80% stenosis, no acute angle and yes bifurcating.The access site was the radial artery, and the characteristics were no calcium, tortuosity, stenosis, acute angle or bifurcating.Angiography revealed more than 80% stenosis of the left anterior descending coronary branch, which required percutaneous coronary intervention (pci).A contralateral approach was not used.The operator had been trained.The patient has a history of coronary artery disease who was admitted to the hospital with anterior cardiac pain.The patient has no infectious diseases.A non- sterile catheter ¿6f.070 xb 3 100cm¿ was received for analysis.During visual inspection several kinked/bent conditions were observed located approximately 3cm, 17cm, 40.5cm, 88cm and 90cm from the distal tip.No other damages or anomalies were observed.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 18184724 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿brite tip/distal tip~frayed/split/torn¿ was not confirmed, the distal tip does not present any damages.However, several kinks were observed on the body/shaft of the returned catheter.The exact cause of these damages could not be conclusively determined during the analysis.However, shipping/handling factors 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.Inspect the guiding catheter before use to verify that its size, shape and condition are suitable for the specific procedure.¿ 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: VISTA BRITE TIP
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17508688
• Report Number: 9616099-2023-06575
• Device Sequence Number: 15006790
• Product Code: DQY
• UDI-Device Identifier: 20705032020142
• UDI-Public: (01)20705032020142(17)260131(10)18184724
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021593
• 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
• Report Date (Section B): 09/20/2023

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
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 67005200
• Device Lot Number: 18184724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• 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: 07/17/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ANOTHER UNKNOWN GUIDING CATHETER.
• Patient Age: 76 YR
• Patient Sex: Male