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

Catalog Number	451418S0
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported a 4f 80cm uniselect (usl) 2 tempo diagnostic catheter started to fall apart at the hub.The catheter looked like it was disintegrated around the hub.It appeared dry, rotted, and splintered.There were no reports of patient injury.The ir lab was using the catheter for a "y90 producer".A contralateral approach was not used.There was acute angulation and bifurcation of the target site vessel.There was also bifurcation of the access site vessel.The device was pulled from the packaging by the hub and body of the catheter.The device was torqued or ¿steered¿ by the hub.A non-sterile unit ¿cath tempo 4f usl 2 80cm¿ was received for analysis.During visual inspection, a cracked condition was noted on the strain relief and on the body/shaft.The distal area of the strain relief is separated and missing.The unit presents with a discolored condition and has several kinks located approximately 19, 62, and 78 cm from the distal tip.The luer hub does not present with any damages or anomalies.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.The strain relief area was inspected with a vision system confirming the cracked condition.A cracked condition was also observed on the body/shaft.Only a small section of the strain relief remains on the device.The separated material was not returned for analysis.Analytical techniques were carried out over complaint sample and results were compared against a control sample to interpret differences to aid in determining the cause of the cracked conditions observed on the catheter.Ftir analysis confirmed the complaint sample and control sample share an overall similar infrared spectrum corresponding to a polyamide material (nylon), ruling out any change in the formulation of catheter used in complaint unit.Although material degradation is clear on the comparison, as the appearance of the peaks in the complaint sample indicates the change in molecular structure caused by oxidation process that induces chain scissions.This polymer degradation could be responsible for the brittle condition observed and could be caused by an oxidation by an external agent due to environmental conditions and is most likely related to storage conditions and exposure.The dsc analysis of complaint sample confirms the degradation and shows different melting point than control sample (around 164 ºc), this change on heat capacity affected thermal performance and thermoplastic properties.The reported ¿luer hub ~ splintered¿ was not confirmed.The luer hub does not present with any damages or anomalies.However, the malfunction ¿catheter (body/shaft)-cracked¿ was confirmed.The strain relief and the body/shaft present with a cracked condition and strain relief material is separated from the device.Additionally, several kinks were observed on the returned device.The exact cause of the cracked condition, the kinks and the separation of strain relief material could not be conclusively determined during the analysis.However, the most common cause of degradation is light exposure also called photo-oxidation and it affects several synthetic polymers; ultraviolet lights interact with free radicals to produce oxidation, this causes discoloration or yellowing and cracking, in addition, extreme humidity or temperatures can also cause a material¿s degradation during storage.Therefore, the cracking and degradation of the device may have been caused by unsuitable environmental 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, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.Exposure to temperatures above 54o c (130o f) may damage the catheter.¿ based on the available information, 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.
Event or Problem Description
As reported a 4f 80cm uniselect (usl) 2 tempo diagnostic catheter started to fall apart at the hub.The catheter looked like it was disintegrated around the hub.It appeared dry, rotted, and splintered.There were no reports of patient injury.The ir lab was using the catheter for a "y90 producer".A contralateral approach was not used.There was acute angulation and bifurcation of the target site vessel.There was also bifurcation of the access site vessel.The device was pulled from the packaging by the hub and body of the catheter.The device was torqued or ¿steered¿ by the hub.The device will be returned for evaluation.Addendum: per product analysis, the body/shaft presented a cracked condition.
Additional Manufacturer Narrative
After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14021 nw 60 avenue; miami lakes, fl 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18876248
• Report Number: 9616099-2024-00078
• Device Sequence Number: 9050710
• Product Code: DQO
• UDI-Device Identifier: 10705032007887
• UDI-Public: (01)10705032007887(17)260131(10)18185794
• Combination Product (Y/N): N
• 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): Unknown
• 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): 08/14/2024

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: 01/31/2026
• Device Catalogue Number: 451418S0
• Device Lot Number: 18185794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• 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
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White