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

Catalog Number	77805800
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17982725 presented no issues during the manufacturing process that could be related to the event reported.The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the body shaft of a 7f vista brite tip extra back-up 4.5 guiding catheter was found fractured during use in a percutaneous coronary intervention (pci) procedure.There was no reported patient injury.The operator has extensive clinical surgical experience.The product was stored, handled, inspected and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.The tip of the device was visible under fluoroscopy throughout the procedure.Additional event details were requested; however, not provided.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
As reported, the body shaft of a 7f vista brite tip extra back-up 4.5 guiding catheter was found fractured during use in a percutaneous coronary intervention (pci) procedure.There was no reported patient injury.The operator has extensive clinical surgical experience.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.The tip of the device was visible under fluoroscopy throughout the procedure.A non- sterile catheter ¿gc 7f 078 xb 4.5¿ was received for evaluation.During visual inspection kinked/bent conditions were noted approximately 6 cm and 48 cm from the distal tip.The catheter did not present with any cracks.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 17982725 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 ¿catheter (body/shaft)-cracked¿ was not confirmed.The catheter does not have a crack however, kinks were noted along the body/shaft.Patient specific vessel characteristics or handling factors may have contributed to the 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, ¿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.Torquing the guiding catheter excessively while kinked may cause damage which could result in possible separation along the catheter shaft.Should the guiding catheter shaft become severely kinked, withdraw the entire system (guiding catheter, guidewire, and catheter sheath introducer)¿ 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.
Additional Manufacturer Narrative
The 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.

• Brand Name: VISTA BRITE TIP
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17455504
• Report Number: 9616099-2023-06569
• Device Sequence Number: 16828045
• Product Code: DQY
• UDI-Device Identifier: 20705032021910
• UDI-Public: (01)20705032021910(17)230930(10)17982725
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K972978
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 77805800
• Device Lot Number: 17982725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/07/2023; 09/13/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/31/2023; 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2020
• 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: UNK.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic