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

Model Number 451531H2

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 288901558
• Report Number: 9616099-2022-05377
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032008594
• UDI-Public: 10705032008594
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 451531H2
• Device Catalogue Number: 451531H2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN CATHETER; UNKNOWN GUIDEWIRE