MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 JL3 100CM; CATHETER, PERCUTANEOUS

Catalog Number	67000000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During an unknown procedure, a femoral approach was taken using a vista brite guiding catheter 6f.070 jl3 100cm, and the provider noted difficulty to engage the vessel, after some manipulation of the guide catheter, it developed a kink.Attempts were made to undo the kink by turning in the opposite direction of the torque; however, the guide catheter broke.The patient was sent to surgery and the catheter was removed successfully.Additional procedural details were requested but are unknown.The device was not returned for analysis.A product history record (phr) review of lot 17805904 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The reported, ¿catheter (body/shaft) kinked/bent - in-patient¿, ¿catheter (body/shaft) separated - in-patient¿, and ¿catheter (body/shaft) cannulation difficulty¿ could not be confirmed as the device was not returned for analysis and procedural films were not received for analysis.The exact cause of the reported events could not be conclusively determined.Based on the limited information available for review, patient and procedural factors may have contributed to the reported events.Per the instructions for use (ifu), which is not intended as a mitigation, ¿precautions: 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.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).Advancement, manipulation and withdrawal of the guiding catheter should always be performed under fluoroscopic guidance.¿ neither the phr review nor the event description suggests that the reported events could be related to the manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.(b)(4).
Event or Problem Description
As reported, femoral approach was taken using a vista brite guiding catheter 6f.070 jl3 100cm, and the provider noted difficulty to engage and after some manipulation of the guide catheter, it developed a kink.Attempts were made to undo the kink by turning in the opposite direction of the torque; however, the guide catheter broke.The patient was sent to surgery and the catheter was removed successfully.Additional procedural details were requested but are unknown.

• Brand Name: 6F .070 JL3 100CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8574654
• Report Number: 9616099-2019-02892
• Device Sequence Number: 16204396
• Product Code: DQY
• UDI-Device Identifier: 20705032019856
• UDI-Public: 20705032019856
• Combination Product (Y/N): N
• Initial Reporter State: SC
• PMA/510(K) Number: K021593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2019
• Report Date (Section F): 03/21/2019

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: 08/31/2021
• Device Catalogue Number: 67000000
• Device Lot Number: 17805904
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Date Report Sent to FDA: 03/21/2019