MAUDE Adverse Event Report: CATH TEMPO 4F USL 2 80CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	451418S0
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is not available for testing and evaluation.A review of the manufacturing documentation associated with this lot# 17951293 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 or Problem Description
As reported, the tip of a 4f 80cm uni select i (usl) tempo catheter snapped off inside the patient.There was no reported patient injury.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, the tip of a 4f 80cm uni select i (usl) tempo catheter snapped off inside the patient.There was no reported patient injury.The product was not returned for analysis.A product history record (phr) review of lot 17951293 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 reported event could not be conclusively determined.Handling factors, such as excessive force, may have contributed to the reported event.According to 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.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure.¿ neither the phr review nor the information available suggests that the reported event 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 4F USL 2 80CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10960458
• Report Number: 9616099-2020-04100
• Device Sequence Number: 791464
• Product Code: DQO
• UDI-Device Identifier: 20705032007884
• UDI-Public: 20705032007884
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K973401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/18/2021

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: 05/31/2023
• Device Model Number: 451418S0
• Device Catalogue Number: 451418S0
• Device Lot Number: 17951293
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 01/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.