MAUDE Adverse Event Report: CORDIS CORPORATION GC 5F 056 XB 3.5 LBT; CATHETER, PERCUTANEOUS

Model Number	5560540L
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the tip of 5f.056 extra back-up (xb) 3.5 long vista brite tip guiding catheter was defective.As a result the catheter was changed.There was no reported patient injury.The device was used in an interventional cardiology procedure.Additional procedural details were requested but are unknown.The device was returned for evaluation.As per product evaluation, during the visual inspection, the unit presented a torn condition located approximately at 6.1 cm from distal tip.Due the torn condition found on the unit, a sem analysis was performed, and results showed that the torn area of the body/shaft from the gc 5f 056 xb 3.5 lbt unit presented evidence of elongations.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the tip of 5f.056 extra back-up (xb) 3.5 long vista brite tip guiding catheter was defective.As a result, the catheter was changed.There was no reported patient injury.The device was used in an interventional cardiology procedure.One non-sterile unit of catheter gc 5f 056 xb 3.5 lbt was for analysis.The device was unpacked to proceed with the product evaluation.During visual inspection, the unit presented with a torn condition located approximately at 6.1 cm from distal tip.Also, a couple of compressed conditions were found located approximately at 23.5 cm from distal tip.A twisted condition was found located approximately at 39.7 cm from distal tip and a kinked condition was found approximately at 85.4 cm from distal tip.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Sem analysis was performed, and results showed that the torn area of the body/shaft from the gc 5f 056 xb 3.5 lbt unit presented evidence of elongations.Also, ductile dimples were found on the separated braid wire surfaces.A product history record (phr) review of lot 18006799 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event by the customer as ¿catheter (body/shaft) ¿ cracked - in-patient¿ was confirmed since a torn condition was found near the distal tip.The elongations found on the body/shaft material of the unit are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body/shaft material was induced to a tensile force that exceeded the body/shaft material yield strength prior to the separation.User technique, vessel characteristics and/or inappropriate selection of a concomitant device may have contributed to the reported event.Although not intended as a mitigation of risk, 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), ¿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, product 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: GC 5F 056 XB 3.5 LBT
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13012003
• Report Number: 9616099-2021-05193
• Device Sequence Number: 4769231
• Product Code: DQY
• UDI-Device Identifier: 20705032015223
• UDI-Public: (01)20705032015223(17)240229(10)18006799
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K000715
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2021

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: 02/29/2024
• Device Model Number: 5560540L
• Device Catalogue Number: 5560540L
• Device Lot Number: 18006799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown