MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F SIM 1 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	451430H0
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: the tip of a 4f tempo catheter was found fractured during prep.There was no reported patient injury.An unknown guidewire was unable to cross the 4f tempo catheter and the procedure cannot continue.An unknown catheter was used to complete the procedure.This was for an angiographic examination for a bronchi artery to confirm bleeding on the location and target vessel.The device was stored and handled per the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the products from the packaging.There were no anomalies noted when the device was taken out of the package.There were no difficulty removing the stylet or any of the sterile packaging components.The product was not re-sterilized.The device was prepped following the ifu.There were no anomalies noted during or after the device was prepped.The lesion had no calcification.There was severe tortuosity on the vessel.The percentage of stenosis was 75%.The device was not used for chronic total occlusion (cto).There were no kinks or other damages noted prior to inserting the product into the patient.There was no resistance when advancing the device.There was no unusual force used at any time during the procedure.The device was not returned for analysis.A product history record (phr) review of lot 17865415 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 ¿brite tip/distal tip - catheters- cracked - 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, ¿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
The tip of a 4f 100cm tempo catheter was found fractured during prep.There was no reported patient injury.An unknown guidewire was unable to cross the 4f 100cm tempo catheter and the procedure cannot continue.An unknown catheter was used to complete the procedure.This was for an angiographic examination for a bronchi artery to confirm bleeding on the location and target vessel.The device was stored and handled per the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the products from the packaging.There were no anomalies noted when the device was taken out of the package.There were no difficulty removing the stylet or any of the sterile packaging components.The product was not re-sterilized.The device was prepped following the ifu.There were no anomalies noted during or after the device was prepped.The lesion had no calcification.There was severe tortuosity on the vessel.The percentage of stenosis was 75%.The device was not used for chronic total occlusion (cto).There were no kinks or other damages noted prior to inserting the product into the patient.There was no resistance when advancing the device.There was no unusual force used at any time during the procedure.The device will not be returned for evaluation.The hospital has reported this case as an adverse event to (b)(6).

• Brand Name: CATH TEMPO 4F SIM 1 100CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10040641
• Report Number: 9616099-2020-03692
• Device Sequence Number: 14156413
• Product Code: DQO
• UDI-Device Identifier: 20705032007921
• UDI-Public: 20705032007921
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2020

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: 04/30/2022
• Device Model Number: 451430H0
• Device Catalogue Number: 451430H0
• Device Lot Number: 17865415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 67