MAUDE Adverse Event Report: CORDIS CASHEL CATH TEMPO 5F C2 65CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	451543V0
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not yet returned to manufacture.A review of the manufacturing documentation associated with lot 17798734 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 5f c2 65cm tempo catheter collapsed twice and did not recover its original shape which has hindered the removal of the catheter by using the introducer.There was no reported patient injury.The product was withdrawn from the patient and a puncture site has been made.
Additional Manufacturer Narrative
During an unknown procedure, a 5f c2 65cm tempo catheter collapsed twice and did not recover its original shape which has hindered the removal of the catheter by using the introducer.There was no reported patient injury.The product was withdrawn from the patient and a puncture site has been made.Additional procedural details were requested but not provided.The device was not returned for analysis.A product history record (phr) review of lot 17798734 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported events ¿brite tip/distal tip catheters- prolapse¿ and ¿catheter (body/shaft)- withdrawal difficulty through sheath¿ could not be confirmed as the device was not returned for analysis.The exact root cause could not be conclusively determined.Vessel characteristics, although not provided, and/or procedural factors may have contributed to the reported event.According to the instructions for use (ifu), which is not intended as a mitigation of risk, ¿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.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.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi) and into the left ventricle.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.Before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.Keep the catheter filled with either flushing solution or contrast medium while the catheter is in the vascular system and consider the use of systemic heparinization.Forcibly aspirate and flush the catheter with heparinized saline solution at least once every two minutes.¿ neither the phr review nor the information available suggests that the reported failures could be related to the manufacturing process of the unit.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: CATH TEMPO 5F C2 65CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road,; cashel, co. tipperary ; EI
• MDR Report Key: 8879351
• Report Number: 9616099-2019-03130
• Device Sequence Number: 2028800
• Product Code: DQO
• UDI-Device Identifier: 20705032008676
• UDI-Public: 20705032008676
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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: 06/30/2021
• Device Model Number: 451543V0
• Device Catalogue Number: 451543V0
• Device Lot Number: 17798734
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CSI.