MAUDE Adverse Event Report: CORDIS CORPORATION SUPER TORQUE MB; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	532598C
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	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported the gold-alloy marker bands detached from 5f pigtailed 65cm 8 side hole (sh) super torque angiographic catheter during usage.They stayed blocked in the sheath.There were no reports of patient injury.The device will be returned for evaluation.
Additional Manufacturer Narrative
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.
Event or Problem Description
As reported the gold-alloy marker bands detached from 5f pigtailed 65cm 8 side hole (sh) super torque angiographic catheter during usage.They stayed blocked in the sheath.There were no reports of patient injury.The marker bands did not come off inside the patient.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h2, h3, h6, and h10.Complaint conclusion: as reported the gold-alloy marker bands detached from 5f pigtailed 65cm 8 side hole (sh) super torque angiographic catheter during usage.They stayed blocked in the sheath.There were no reports of patient injury.The marker bands did not come off inside the patient.A non-sterile unit of ¿cath mb 5f pig 65cm 8sh¿ was received for analysis.The unit was thoroughly inspected observing that the 20 markers band are out of position.All 20 marker bands were present at the catheter body.No other outstanding details were observed.Inner diameter (id) and outer diameter (od) measurements were taken between the assigned places for markers bands that are offset/out of position and were found out of specification.This condition was caused by the out of position marker bands compressing the body, which reduced the inner and the outer diameter.Functional analysis was performed by inserting a lab sample guidewire inside the catheter via distal tip.The guide wire could not be passed all the way through the catheter body, traveling only until it reaches the first marker band that is out of position.This condition was caused by the out of position marker bands compressing and reducing the body/shaft internal diameter.The unit was inspected with a vision system observing that the surface of the marker bands did not present evidence of damage (scratches, peelings, abrasions, etc.).The reported ¿marker band (supertorque mb) ~dislodged¿ was not confirmed because all 20 marker bands are present on the catheter body.However, all 20 marker bands were observed to be out of position.Excessive manipulation of the catheter while the device was trapped in the patient¿s vasculature may have contributed to the reported event as this scenario can lead to elongation of the catheter and cause the marker bands to move out of position.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, ¿contraindications: do not use the super torque mb catheter in procedures where entrapment of the catheter between endovascular devices and the vessel wall may occur, for example endovascular aortic repair (evar) procedures.Manipulation of the catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter.Stretching or elongation of the catheter during endovascular procedures could result in the marker bands moving along the catheter.In extreme cases, marker bands may come off the catheter and dislodge into the vascular system.¿ 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.
Additional Manufacturer Narrative
After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.

• Brand Name: SUPER TORQUE MB
• 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 FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 19322284
• Report Number: 9616099-2024-00155
• Device Sequence Number: 6339001
• Product Code: DQO
• UDI-Device Identifier: 10705032012041
• UDI-Public: (01)10705032012041(17)271231(10)18276042
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K915836
• 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,Followup
• Report Date (Section B): 08/27/2024

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 Catalogue Number: 532598C
• Device Lot Number: 18276042
• 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: 04/24/2024
• Supplement Date Received by Manufacturer: 05/22/2024; 06/21/2024; 08/27/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/18/2024; 07/08/2024; 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown