MAUDE Adverse Event Report: CORDIS CORPORATION 5 F TEMPO 0.038" 125CM VERT135; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	SRD6892
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a complaint received from medwatch (b)(4).Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
During a stroke intervention case, a 5f tempo vertebral 135 degree catheter was being prepped.The catheter was placed inside a non-cordis guide catheter and the md noticed that catheter radiopaque tip was non existent and removed catheter out of guide catheter.By placing a brand new vertebral catheter, md fluoro¿d prior to treatment and noticed the broken tip was intact and inside the guide catheter.He then continued to remove both catheters out successfully without patient injury.
Additional Manufacturer Narrative
During a stroke intervention case, a 5f tempo vertebral 135 degree catheter was prepped and placed inside a non-cordis guide catheter; however, the md noticed that catheter¿s radiopaque tip was non-existent and removed the catheter out of the guide catheter.By placing a brand new vertebral catheter, the md fluoroscoped prior to treatment and noticed the broken tip was intact and inside the guide catheter.He removed both catheters out successfully without patient injury.No other information was provided.The device was not returned for analysis.A device history record (dhr) review of lot 17675395 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿brite tip/distal tip separated in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause of the separation could not be determined.Based on the information available for review, procedural/handling factors (although non-cordis size and resistance information was not provided) may have contributed to the distal tip separation reported.According to the instructions for use (ifu), ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Exercise care when removing guidewires from multiple-curve catheters.Treat all 4f (1.35 mm) catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.

• Brand Name: 5 F TEMPO 0.038" 125CM VERT135
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 6875693
• Report Number: 9616099-2017-01432
• Device Sequence Number: 13587887
• Product Code: DQO
• UDI-Device Identifier: 20705032051771
• UDI-Public: 20705032051771
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K973401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2017

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: 04/30/2020
• Device Model Number: SRD6892
• Device Catalogue Number: SRD6892
• Device Lot Number: 17675395
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/23/2017
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 11/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1