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

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17964856 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 5f.056¿ judkin¿s left 3.5 (jl3.5) long vista brite tip guiding catheter was circulated when a fracture was observed in the body of the catheter.Therefore, the specialist requested a change of input and a new unknown catheter was circulated.The device has no contact with the patient or fluids.There was no reported patient injury.The device was intended to be used in an angioplasty procedure.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: a 5f.056¿ judkin¿s left 3.5 (jl3.5) long vista brite tip guiding catheter was circulated when a fracture was observed in the body of the catheter.Therefore, the specialist requested a change of input and a new unknown catheter was circulated.The device has no contact with the patient or fluids.The device was intended to be used in an angioplasty procedure.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 17964856 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Based on the information provided, it is not possible to draw a clinical conclusion between the devices and the reported event.Without the return of the devices for analysis, the reported customer event ¿catheter (body/shaft) - cracked - during prep¿ could not be confirmed and the exact root cause could not be determined.Storage or handling factors may have contributed to the reported event.Per the instructions for use (ifu), which is not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use open or damaged packages.Do not resterilize.Do not expose to organic solvents.Inspect the guiding catheter before use to verify that its size, shape, and condition are suitable for the specific procedure.¿ the recommended procedure section in the ifu states, ¿remove the guiding catheter from its packaging.Inspect the guiding catheter upon removal from packaging to verify that it is undamaged.Warning: do not use a guiding catheter that has been damaged in any way.If damage is detected, replace with an undamaged guiding catheter.¿ neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.
Event or Problem Description
As reported, a 5f.056¿ judkin¿s left 3.5 (jl3.5) long vista brite tip guiding catheter was circulated when a fracture was observed in the body of the catheter.Therefore, the specialist requested a change of input and a new unknown catheter was circulated.The device has no contact with the patient or fluids.There was no reported patient injury.The device was intended to be used in an angioplasty procedure.The device was returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, a 5f.056¿ judkin¿s left 3.5 (jl3.5) long vista brite tip guiding catheter was circulated when a fracture was observed in the body of the catheter.Therefore, the specialist requested a change of input and a new unknown catheter was circulated.The device has no contact with the patient or fluids.There was no reported patient injury.The device was intended to be used in an angioplasty procedure.One non-sterile unit of a vista brite tip catheter (gc 5f 056 jl 3.5 lbt) was received for analysis.During the visual inspection, a few kinked conditions were found located approximately at 33.3, 45.1 and 80.8 cm from distal tip.No other anomalies were found along the device.Dimensional analysis was performed to verify the correct catheter inner diameter (id) and outer diameter (od), measurements were taken near the damages.Dimensional analysis result was found within specification.Functional analysis was performed.A flushing test was attempted, no difficulty, leak or any other anomaly was noted during the test.A product history record (phr) review of lot 17964856 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 - during prep¿ was not confirmed since no crack was found during visual inspection or functional analysis.However, a few kinks were noted during analysis.Dimensional analysis was performed, and it was found within specification.The exact cause of the conditions found could not be conclusively determined during the analysis.Procedural and/or handling factors might have contributed to the reported conditions on the unit since the device did not present any obvious indication of manufacturing defect or anomaly that could contribute to the event as reported.According to the instructions for use (ifu), which is not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use open or damaged packages.Do not resterilize.Do not expose to organic solvents.Inspect the guiding catheter before use to verify that its size, shape, and condition are suitable for the specific procedure.¿ the recommended procedure section in the ifu states, ¿remove the guiding catheter from its packaging.Inspect the guiding catheter upon removal from packaging to verify that it is undamaged.Warning: do not use a guiding catheter that has been damaged in any way.If damage is detected, replace with an undamaged guiding catheter.¿ neither the phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.No corrective or preventive actions will be taken.

• Brand Name: GC 5F 056 JL 3.5 LBT
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11470218
• Report Number: 9616099-2021-04332
• Device Sequence Number: 4041641
• Product Code: DQY
• UDI-Device Identifier: 20705032015186
• UDI-Public: 20705032015186
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2021

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: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 5560020L
• Device Lot Number: 17964856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 03/17/2021; 04/09/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 03/18/2021; 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1