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	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 5f 65 cm super torque mb pigtail (pig) angiographic catheter, snapped in half/sheared off inside the body.It was safely removed over a non-cordis wire.There was no reported patient injury.The device was not resterilized.Additional information was requested but not provided.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.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b3, g3, g6, h1, h2, h3, h6, and h11.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 5f 65 cm super torque mb pigtail (pig) angiographic catheter, snapped in half/sheared off inside the body.It was safely removed over a non-cordis wire.There was no reported patient injury.The device was not resterilized.There were no any anomalies noted when removed from the package and/or during prep.Additional information was requested but not provided.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, a 5f 65 cm super torque mb pigtail (pig) angiographic catheter, snapped in half/sheared off inside the body.It was safely removed over a non-cordis wire.There was no reported patient injury.The device was not resterilized.There were no anomalies noted when removed from the package and/or during prep.Additional information was requested but not provided.One non-sterile unit of a cath mb 5f pig 65cm 8sh was received coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.During the visual inspection, a separated condition was noted at the catheter body, located approximately at 25.2 cm from the distal tip.Both separated portions of the unit were returned for analysis.No other anomalies in the hub, tip, nor body/shaft were noted.Due the separated condition on the unit, a microscopical analysis was performed.An sem analysis was not required since the separation characteristics were observed using the vision system.Results showed that the separated area of the unit presented evidence of elongations.No other anomalies were observed during the analysis.The reported event by the customer as ¿catheter (body/shaft) ¿ separated¿ was confirmed since a separation was noted on the body of the catheter.A microscopical analysis was performed and, results showed that the separated area of the unit presented evidence of elongations.The elongations found on the plastic material of the unit are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the unit was induced to a tensile force that exceeded the material yield strength prior to the separation.Procedural and/or handling factors might have contributed to the condition found on the unit since the device did not present any obvious indication of manufacturing defect or anomaly that could contribute to the event as reported.According to the instructions for use (ifu), which is not intended as a mitigation, the catheter should be stored in a cool, dark, dry place.To prevent damage to the catheter during removal from the package, grasp the hub (as was done in this case) and withdraw the catheter.To prevent damage to the catheter, straighten the tip only with a diagnostic guidewire or tip straightener.Do not straighten by hand.Use a guidewire when introducing the catheter through the sheath.Based on the information available for review, there is no indication to suggest that the reported failure could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.

• Brand Name: SUPER TORQUE MB
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 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: 20396158
• Report Number: 9616099-2024-00340
• Device Sequence Number: 8037761
• Product Code: DQO
• UDI-Device Identifier: 10705032012041
• UDI-Public: (01)10705032012041(17)270630(10)18340162
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2024

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: 18340162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• 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: 09/13/2024
• Supplement Date Received by Manufacturer: 10/09/2024; 11/11/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/01/2024; 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2024
• 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: COOK LUNDERQUIST WIRE
• Patient Sex: Unknown