MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 JL4 100CM; CATHETER, PERCUTANEOUS

Model Number 67000400

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2020

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

A.070 judkins left (jl) 4 x 100cm 6f vista bite tip coronary guiding catheter twisted in a patient during use, the operator attempted to "un-twist" catheter, when failing to do so, attempted to pull the catheter out of the body; but the catheter then broke off in the body.The patient taken to surgery to remove remaining catheter piece (the tip), successfully.The device is available for an on-site evaluation only.

Manufacturer Narrative

Complaint conclusion: a 6f vista brite tip coronary guiding catheter twisted in a patient during use, the operator attempted to "un-twist" catheter, when failing to do so, attempted to pull the catheter out of the body; but the catheter then broke off in the body.The patient was taken to surgery to remove remaining catheter piece (the tip), successfully.Additional procedural details were requested but not provided.The device was not returned for analysis.A product history record (phr) review of lot 17820194 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Based on the limited information provided, it is not possible to draw a clinical conclusion between the device and the reported event.Without the return of the device for analysis, the reported customer events ¿catheter (body/shaft) - kinked/bent - in-patient¿ and ¿catheter (body/shaft) - separated - in-patient¿ could not be confirmed and the exact root cause could not be determined.Vessel characteristics, although not provided, and/or procedural/handling factors may have contributed to the reported event.According to the instructions for use, which is 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 can not 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.Extreme care must be taken to avoid damage to the vasculature through which the guiding catheter passes.¿ neither the phr review nor the information available suggests that the reported failure could be related to the manufacturing process of the unit.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: 6F .070 JL4 100CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 9835531
• MDR Text Key: 190011742
• Report Number: 9616099-2020-03563
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 20705032019887
• UDI-Public: 20705032019887
• Combination Product (y/n): N
• PMA/PMN Number: K021593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 67000400
• Device Catalogue Number: 67000400
• Device Lot Number: 17820194
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 04/03/2020
• Supplement Dates FDA Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 88