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

Model Number	67005400
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18095904 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/distal tip of a 6f vista brite tip xb 3.5 guiding catheter was found fractured.The device did not fracture into two or more pieces.The procedure was completed with a different unknown guiding catheter.This event had no effect on the patient.There was no reported patient injury.The device was pulled from the packaging by the hub.The device was not torqued or ¿steered¿ by the hub.The patient has a previous history of coronary artery disease who was admitted with anterior heart pain.The target site was moderately calcified and with mild tortuosity.The stenosis percentage was 80%.There was no acute angle or bifurcating.The access site did not have calcium or tortuosity.The access site did not have stenosis, acute angle, or bifurcation.An unknown cordis sheath was used.The angiography revealed more than 80% stenosis of the anterior descending branch of the left coronary requiring a percutaneous coronary intervention (pci) and a contralateral approach was not used.The operator had been trained to use our xb 3.5 guiding catheter.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the brite tip/distal tip of a 6f vista brite tip xb 3.5 guiding catheter was found fractured.The device did not fracture into two or more pieces.The procedure was completed with a different unknown guiding catheter.This event had no effect on the patient.There was no reported patient injury.The device was pulled from the packaging by the hub.The device was not torqued or ¿steered¿ by the hub.The patient has a previous history of coronary artery disease who was admitted with anterior heart pain.The targe site was moderately calcified and with mild tortuosity.The stenosis percentage was 80%.There was no acute angle or bifurcating.The access site did not have calcium or tortuosity.The access site did not have stenosis, acute angle, or bifurcation.An unknown cordis sheath was used.The angiography revealed more than 80% stenosis of the anterior descending branch of the left coronary requiring a percutaneous coronary intervention (pci) and a contralateral approach was not used.The operator had been trained to use our xb 3.5 guiding catheter.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device was returned for analysis.A non-sterile unit of catheter (6f.070 xb 3.5 100cm) was received coiled inside of a clear plastic bag.The part was unpacked in order to proceed with the product evaluation.During visual analysis the inspection observed kink/bent condition on the body of the catheter was observed at 3 and 52 cm from the distal tip.No other damages or anomalies were observed on the returned device.Per dimensional analysis the inner and outer diameters were measured near the damaged areas and found to be within specification.A product history record (phr) review of lot 18095904 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿brite tip/distal tip - cracked¿ was not confirmed during analysis of the returned device as there was no evidence of a crack condition observed on the device.The unit, however, did present with several areas of kinking of the catheter.The exact cause for the kink conditions found on the catheter could not be determined as images of the catheter prior to shipping were not provided.Procedural/handling and or shipping factors may have contributed to the condition of the catheter.Information for safety is provided in the products labeling with the intent to make the user aware of the risks and warns the user to not use a guiding catheter that has been damaged in any way.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿inspect the catheter upon removal from packaging to verify that is undamaged, if damage is detected do not use the catheter and select another one.Based on the information available, the device 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: 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: 16903309
• Report Number: 9616099-2023-06491
• Device Sequence Number: 5561497
• Product Code: DQY
• UDI-Device Identifier: 20705032020166
• UDI-Public: (01)20705032020166(17)250228(10)18095904
• 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): 07/17/2023

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: 02/28/2025
• Device Model Number: 67005400
• Device Catalogue Number: 67005400
• Device Lot Number: 18095904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• 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: 04/17/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CORDIS SHEATH
• Patient Age: 69 YR
• Patient Sex: Male