MAUDE Adverse Event Report: CORDIS CORPORATION TEMPO; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	451531H0
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product history review is expected but has not been completed.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, while manipulating the angle of a 5f 100cm sidewinder 2 tempo diagnostic catheter, the catheter fractured at about 40cm from the proximal end of the catheter.This occurred as a result of rotating the catheter several times outside the body.A "catcher" was used to grab the broken contrast tube out of the body.The patient was not harmed from this contrast catheter.The operation ended midway, and no other treatment was given to the patient.Interventional surgeons had been attempting to perform left subclavian artery angiography on the patient, and the diagnostic catheter had been delivered to the left subclavian artery from the femoral artery.A contralateral approach was used.The target site was mildly calcified and severely tortuous.It also had acute angulation and bifurcation in the vessel.There was 90% stenosis of the target site.On the other hand, there was no calcification, tortuosity, acute angulation or bifurcation of the access site vessel.The device was pulled from the packaging by the hub.The device was not torqued or ¿steered¿ by the hub.The catheter did not become entrapped at any point in the procedure.The user was trained in the use of the device.The device was stored and prepped in accordance with the instructions for use (ifu).The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, while manipulating the angle of a 5f 100cm sidewinder 2 tempo diagnostic catheter, the catheter fractured at about 40cm from the proximal end of the catheter.This occurred because of rotating the catheter several times outside the body.A "catcher" was used to remove the broken contrast tube from the body.The patient was not harmed from this contrast catheter.The operation ended midway, and no other treatment was given to the patient.Interventional surgeons had been attempting to perform left subclavian artery angiography on the patient, and the diagnostic catheter had been delivered to the left subclavian artery from the femoral artery.A contralateral approach was used.The target site was mildly calcified and severely tortuous.It also had acute angulation and bifurcation in the vessel.There was 90% stenosis of the target site.On the other hand, there was no calcification, tortuosity, acute angulation, or bifurcation of the access site vessel.The device was pulled from the packaging by the hub.The device was not torqued or ¿steered¿ by the hub.The catheter did not become entrapped at any point in the procedure.The user was trained in the use of the device.The device was stored and prepped in accordance with the instructions for use (ifu).A non-sterile unit of ¿cath tempo 5f sim 2 100cm¿ was received for evaluation.The device was received separated in two pieces and both segments were returned.The separation is located approximately 43 cm from the proximal end.The unit presents with one kink located approximately 25.5 cm from the distal tip.Severe damage located approximately 47 cm from the distal tip and extending to the separated edge was noted and is comprised of a twisted, kinked, and compressed condition.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.The separated area was inspected with a vision system.Both separated edges presented with evidence of elongations on the plastic material, plastic deformation, and diameter reduction on the body shaft.Diameter reduction and plastic deformation on the braidwire was also observed.A product history record (phr) review of lot 18095027 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-separated¿ was confirmed.The unit was returned separated in two pieces.The exact cause of these damages could not be conclusively determined during the analysis.The elongations, plastic deformations and diameter reduction observed at the separated edges are commonly 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.Excessive manipulation of the catheter is a possible contributing factor.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.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18095027 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.Corrected/missing data: updated section with udi number.Updated section with type of investigation code of 3331.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14021 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: 17056756
• Report Number: 9616099-2023-06512
• Device Sequence Number: 20960081
• Product Code: DQO
• UDI-Device Identifier: 10705032008587
• UDI-Public: (01)10705032008587(17)250228(10)18095027
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: 451531H0
• Device Lot Number: 18095027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/10/2023
• Supplement Date Received by Manufacturer: 06/08/2023; 08/30/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 06/08/2023; 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2022
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 36 KG