MAUDE Adverse Event Report: CORDIS US CORP. TEMPO; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 451515V0

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

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

Event Date 05/16/2023

Event Type  malfunction  

Event Description

As reported a 5f tempo berenstein (bern) 2 angiographic catheter was noted to be fractured in multiple areas halfway down the catheter right to the distal tip during a fistulaplasty.The procedure was completed by using another equipment.There was no reported patient injury.Target lesion, access site, lesion characteristics and percentage stenosis were not provided.It is unknown if the device was used for a chronic total occlusion (cto).The product was stored, handled, inspected and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.There was no device damage noted prior to inserting the device in the patient.The patient was not hospitalized nor was the patient's hospitalization extended because of the event.The device was removed intact (in one piece) from the patient.The device is expected to be returned for evaluation.Two device images were provided for review.Report is being sent from the hospital to tga.

Manufacturer Narrative

The product history record review is anticipated; however, it has not yet been finalized.The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17974187 presented no issues during the manufacturing process that could be related to the event reported.The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported a 5f tempo berenstein (bern) 2 angiographic catheter was noted to be fractured in multiple areas halfway down the catheter right to the distal tip during a fistulaplasty.The procedure was completed by using another device.There was no reported patient injury.Target lesion, access site, lesion characteristics and percentage stenosis were not provided.It is unknown if the device was used for a chronic total occlusion (cto).The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.There was no device damage noted prior to inserting the device in the patient.The patient was not hospitalized nor was the patient's hospitalization extended because of the event.The device was removed intact (in one piece) from the patient.The device is expected to be returned for evaluation.Two device images were provided for review.Two pictures related to the reported failure were submitted for analysis.The catheter was noted to be severely damaged with cracks and kinks.A unit of catheter cath tempo 5f ber ii 65cm was subsequently received for evaluation.During visual inspection, the catheter was noted to be separated 17 cm from the distal tip.Additionally, several cracks from 4.5 cm to 15.5 cm were noted.No other damages or anomalies were observed on the returned device.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.The separated area was observed under the vision system to magnify the damages and presented evidence of elongations on the plastic and plastic deformation.A product history record (phr) review of lot 17974187 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿catheter (body/shaft)- cracked¿ was confirmed since several cracks were noted on the catheter body.Additionally, a separation was found on the body of the catheter, which confirmed the reported ¿catheter (body/shaft)- separated.¿ while the exact cause of the separation cannot be conclusively determined, elongations and plastic deformation is commonly associated with separations caused by material tensile/twist overload.Therefore, it is assumed that the material was induced to tensile/twist forces that exceeded the material yield strength prior to the separation.Handling factors such as torquing the catheter against resistance is a possible underlying cause.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, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.¿ based on the information available and the phr review, 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: TEMPO
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17102219
• MDR Text Key: 316964402
• Report Number: 9616099-2023-06516
• Device Sequence Number: 1
• Product Code: DQO
• 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: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 451515V0
• Device Catalogue Number: 451515V0
• Device Lot Number: 17974187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2020
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: White