MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO 6F .070 JL3.5 100CM; CATHETER, PERCUTANEOUS

Model Number	67000200
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the 6f.070 100cm judkins left (jl 3.5) vista brite tip guiding catheter (gc) will not work with the non-cordis extension catheter.The customer thought the guides are not the same all the way through the lumen.There was no reported patient injury.The device was stored per labelling and opened in sterile field.The device was not used in the patient.Additional procedural details were requested but are unknown.The device was not returned for analysis.A product history record (phr) review of lot 17963839 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis, the reported customer event ¿luer hub ¿ catheters - incompatibility/fit - during prep¿ could not be confirmed and the exact root cause could not be determined.Procedural/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 that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
As reported, the 6f.070 100cm judkins left (jl 3.5) vista brite tip guiding catheter (gc) will not work with the non-cordis extension catheter.The customer thought the guides are not the same all the way through the lumen.There was no reported patient injury.The device was stored per labelling and opened in sterile field.The device was not used in the patient.The device was not returned for analysis.Additional procedural details were requested but are unknown.
Additional Manufacturer Narrative
As reported, the 6f.070 100cm judkins left (jl 3.5) vista brite tip guiding catheter (gc) will not work with the non-cordis extension catheter.The customer thought the guides are not the same all the way through the lumen.There was no reported patient injury.The device was stored per labelling and opened in sterile field.The device was not used in the patient.Additional procedural details were requested but are unknown.A non-sterile unit of a vista brite tip gc (6f.070 jl3.5 100cm) was received for analysis.The unit was thoroughly inspected observing two kinked/bent conditions located at 84.5 and 92 cm approximately from the distal tip.No other damages or anomalies were found on the returned unit.Functional analysis was performed connecting the returned catheter by the hub to a lab sample syringe and an injector tubing.The test results were successful, no anomalies were observed.Dimensional analysis was performed to verify the correct guiding catheter inner diameter (id) and outer diameter (od), and to verify the correct minor and major thread diameter of the hub.Measurements were taken near the damages observed on the catheter body.Dimensional analysis results were found within specification.The hub area was inspected with the aid of vision system to obtain a magnified image.As a result, no anomalies or damages were observed.A product history record (phr) review of lot 17963839 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 ¿luer hub ¿ catheters - incompatibility/fit - during prep¿ was not confirmed, the functional and dimensional analysis results were found within the expected specifications.However, two kinked/bent conditions were observed on the catheter body.Procedural/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 product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: 6F .070 JL3.5 100CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 11812364
• Report Number: 9616099-2021-04539
• Device Sequence Number: 3149481
• Product Code: DQY
• UDI-Device Identifier: 20705032019863
• UDI-Public: 20705032019863
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

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: 67000200
• Device Catalogue Number: 67000200
• Device Lot Number: 17963839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEZILLA