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

Catalog Number	77800400
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the 7f vista brite tip judkins left 4 guiding catheter fractured during use in a percutaneous coronary intervention (pci) procedure.There was no reported patient injury.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).There were no anomalies noted when the product was removed from the packaging.The tip 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
A review of the manufacturing documentation associated with lot 17968676 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.
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.
Additional Manufacturer Narrative
As reported, the 7f vista brite tip judkins left 4 guiding catheter fractured during use in a percutaneous coronary intervention (pci) procedure.There was no reported patient injury.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).There were no anomalies noted when the product was removed from the packaging.The tip was visible under fluoroscopy throughout the procedure.A non- sterile catheter ¿gc 7f 078 jl 4¿ was received for evaluation.During visual inspection, a cracked condition was not observed however, several kinks were observed approximately 5cm, 27cm and 56 cm from the distal tip.No other damages or anomalies were observed during visual analysis.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 17968676 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 unit did not present with any cracks.However, the malfunction ¿catheter (body/shaft) ~ kinked/bent¿ was confirmed.Kinks were noted on the body/shaft of the returned unit.Storage and/or 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, ¿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: 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: 17455376
• Report Number: 9616099-2023-06568
• Device Sequence Number: 16767647
• Product Code: DQY
• UDI-Device Identifier: 20705032021521
• UDI-Public: (01)20705032021521(17)230731(10)17968676
• 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): 11/09/2023

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: 07/31/2023
• Device Catalogue Number: 77800400
• Device Lot Number: 17968676
• 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; 11/01/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/31/2023; 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2020
• 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
• Patient Sex: Unknown