MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 5F SIM 2 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	451531H2
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number to conduct a device history record (dhr) review, it is not possible to determine if the reported failure could be related to the manufacturing process.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 5f tempo sim 2 100cm 2sh diagnostic catheter was found to be kinked as it was removed from the sterile packaging and would not allow an unknown guidewire to advance.It was also reported that the 5f tempo catheter was difficult to remove from the patient.After the 5f tempo catheter was removed, an unknown catheter was able to be used successfully and there was no injury to the patient.It was reported that there was suspicion the device was damaged in transit since the kink was observed during removal from its packaging.The device was prepped per the instructions for use (ifu).Information regarding the device lot number, access site, access vessel characteristics, concomitant medical devices, and the completion of the procedure was requested but is not available and the device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: d4, d8, d9, g3, g4, g6, h1, h2, h3, h6, and h10 complaint conclusion: as reported, a 5f tempo sim 2 100cm 2sh diagnostic catheter was found to be kinked as it was removed from the sterile packaging and would not allow an unknown guidewire to advance.It was also reported that the 5f tempo catheter was difficult to remove from the patient.After the 5f tempo catheter was removed, an unknown catheter was able to be used successfully and there was no injury to the patient.It was reported that there was suspicion the device was damaged in transit since the kink was observed during removal from its packaging.The device was prepped per the instructions for use (ifu).One non sterile unit of catheter cath tempo 5f sim 2 100cm was received for analysis.During visual inspection, kinks were found located at 26.4 and 44.2 cm from the distal tip.A kinked/twisted condition was also noted and extended from 28.4 to 30.2 cm from the distal tip.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.A product history review could not be performed because the lot number is unknown.The reported event by the customer as ¿catheter (body/shaft) ¿ withdrawal difficulty¿ was not confirmed because the complaint could not be properly evaluated due the nature of the complaint.Factors such as vessel characteristics and/or using the device with a known kink may have contributed to the withdrawal difficulty.The reported event by the customer as ¿catheter (body/shaft) ¿ kinked/bent - during prep¿ was confirmed since kinks were found on the body of the unit.Shipping, storage, or handling factors might have contributed to the observed conditions.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿do not use open or damaged packages.Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with the possible complications.¿ based on the information available there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: CATH TEMPO 5F SIM 2 100CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13606936
• Report Number: 9616099-2022-05377
• Device Sequence Number: 1969180
• Product Code: DQO
• UDI-Device Identifier: 10705032008594
• UDI-Public: 10705032008594
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

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 Model Number: 451531H2
• Device Catalogue Number: 451531H2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: UNKNOWN CATHETER; UNKNOWN GUIDEWIRE
• Patient Sex: Unknown