MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F VER 135 DEGREE 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	451414H0
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the physician was ready to perform the angiographic interventional procedure and inspect the 4f 100cm vertebral (ver) 135 degree tempo catheter, it was found that the middle of the catheter was fractured upon removal of the packaging.Therefore, the physician used another product to complete the procedure.There was no reported patient injury.The device was stored as per labelling.The device was stored in the cath lab according to the instructions for use (ifu).The device was prepped per the ifu.There was no difficulty experienced in prepping the device.The target lesion was the right femoral artery.The lesion was not calcified and there was no vessel tortuosity.There was no stenosis and the device was not being used for a chronic total occlusion (cto).The device was not fractured into separate pieces.The device was not returned for analysis as it was discarded.A product history record (phr) review of lot 17884831 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 device and the reported event.Without the return of the device 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/handling factors may have contributed to the reported event.Per the ifu, which is not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.Do not resterilize.Exposure to temperatures above 54oc (130of) may damage the catheter.Exercise care when removing guidewires from multiple-curve catheters.To prevent kinking of 5f (1.65 mm) and smaller angiographic catheters; straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.Treat all 4f 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.¿ users are trained to inspect for kinks and bends, or other signs of damage prior to and during use.Any product with damage is not to be used.Neither the phr review nor the information available suggests that the event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.
Event or Problem Description
As the physician was ready to perform the angiographic interventional procedure and inspect the 4f 100cm vertebral (ver) 135 degree tempo catheter, it was found that the middle of the catheter was fractured upon removal of the packaging.Therefore, the physician used another product to complete the procedure.There was no reported patient injury.The device was stored as per labelling.The device was stored in the cath lab according to the instructions for use (ifu).The device was prepped per the ifu.There was no difficulty experienced in prepping the device.The target lesion was the right femoral artery.The lesion was not calcified and there was no vessel tortuosity.There was no stenosis and the device was not being used for a chronic total occlusion (cto).The device was not fractured into separate pieces.The device will not be returned for analysis as it was discarded.

• Brand Name: CATH TEMPO 4F VER 135 DEGREE 100CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10138799
• Report Number: 9616099-2020-03729
• Device Sequence Number: 2116050
• Product Code: DQO
• UDI-Device Identifier: 10705032007856
• UDI-Public: 10705032007856
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K973401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2020

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: 07/31/2022
• Device Model Number: 451414H0
• Device Catalogue Number: 451414H0
• Device Lot Number: 17884831
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 65