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

Catalog Number 451415V0

Device Problem Crack (1135)

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

Event Date 07/21/2023

Event Type  malfunction  

Event Description

As reported, the distal tip of a 4f 65cm berenstein (bern) 2 tempo diagnostic catheter broke during the removal of the device from the patient and was close to separating.The device was able to be removed easily from the patient and remained in one piece during its removal.There was no reported injury to the patient and no trauma was caused to the patient's artery.This was during a procedure to treat a popliteal artery lesion.The device was never placed in an acute bend during the procedure, and there was no evidence that the catheter was stuck inside of the patient at any point.The device will be returned for evaluation.The hospital reported this event directly to the ansm.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18183160 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.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18183160 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: as reported, the distal tip of a 4f 65cm berenstein (bern) 2 tempo diagnostic catheter broke during the removal of the device from the patient and was close to separating.The device was able to be removed easily from the patient and remained in one piece during its removal.There was no reported injury to the patient and no trauma was caused to the patient's artery.This was during a procedure to treat a popliteal artery lesion.The device was never placed in an acute bend during the procedure, and there was no evidence that the catheter was stuck inside of the patient at any point.A unit of catheter cath tempo 4f ber ii 65cm was received for evaluation.During visual inspection, the brite tip was noted to be cracked.Sem analysis of the tip presented evidence of a cracked condition where material elongation patterns and evidence of material transfer were observed across the borders of the affected section.A product history record (phr) review of lot 18183160 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by as ¿brite tip/distal tip- cracked¿ was confirmed since this condition was present on the tip.Material elongation patterns are commonly caused by excessive tensile force.The material transfer appears related to the displacement of the cracked material.Procedural factors such as catheter manipulating and/or withdrawing against resistance may have contributed to the reported event.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 60 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: 17584270
• MDR Text Key: 321553862
• Report Number: 9616099-2023-06581
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032007870
• UDI-Public: (01)10705032007870(17)260131(10)18183160
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 451415V0
• Device Lot Number: 18183160
• 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: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2023
• 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.
• Patient Sex: Male