MAUDE Adverse Event Report: CORDIS CORPORATION CATH MB 5F PIG 110CM 6SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	532598B
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	11/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18127005 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.
Event or Problem Description
As reported, a 5f pigtail 110cm 6sh (sideholes) super torque catheter separated most probably up to the last marker spot and all the markers have broken off when removing after using an unknown high-pressure machine at first run.When the broken pigtail tip was looked at the markers have also migrated, and did not dislodge but it was unsure if this was at the time when they were trying to non-cordis snare the tip out or before everything happened.Another unknown catheter was used successfully to complete the procedure.The procedure was completed successfully without patient injury.The device was stored, handled, and prepped per the instructions for use (ifu).There were no anomalies noted when removed from the package.The intended procedure was an endovascular aneurysm repair (evar).The device was not inserted through a stopcock instead of a hemostatic valve.There was no resistance met while advancing the device.The lesion was not calcified nor was there vessel tortuosity or vessel angulation.The device was not used for a chronic total occlusion (total occlusion >3 months).There was no excessive torqueing required.The device was not kinked in the area of separation.The device will not be returned for evaluation.
Event or Problem Description
As reported, a 5f pigtail 110cm 6sh (sideholes) super torque catheter separated most probably up to the last marker spot and all the markers have broken off when removing after using another company high-pressure machine at first run.When the broken pigtail tip was looked at the markers have also migrated and did not dislodge but it was unsure if this was at the time when they were trying to non-cordis snare the tip out or before everything happened.Another unknown catheter was used successfully to complete the procedure.The procedure was completed successfully without patient injury.The device was stored, handled, and prepped per the instructions for use (ifu).There were no anomalies noted when removed from the package.There was no damage seen on the product before the procedure.The intended procedure was an endovascular aneurysm repair (evar).The device was not inserted through a stopcock instead of a hemostatic valve.There was no resistance met while advancing the device.The lesion was not calcified nor was there vessel tortuosity or vessel angulation.The device was not used for a chronic total occlusion (total occlusion >3 months).There was no excessive torquing required.The device was not kinked in the area of separation.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, a 5f pigtail 110cm 6sh (sideholes) super torque catheter separated most probably up to the last marker spot and all the markers have broken off when removing after using another company high-pressure machine at first run.When the broken pigtail tip was looked at the markers have also migrated and did not dislodge but it was unsure if this was at the time when they were trying to non-cordis snare the tip out or before everything happened.Another unknown catheter was used successfully to complete the procedure.The procedure was completed successfully without patient injury.The device was stored, handled, and prepped per the instructions for use (ifu).There were no anomalies noted when removed from the package.There was no damage seen on the product before the procedure.The intended procedure was an endovascular aneurysm repair (evar).The device was not inserted through a stopcock instead of a hemostatic valve.There was no resistance met while advancing the device.The lesion was not calcified nor was there vessel tortuosity or vessel angulation.The device was not used for a chronic total occlusion (total occlusion >3 months).There was no excessive torquing required.The device was not kinked in the area of separation.The product was not returned for analysis.A product history record (phr) review of lot 18127005 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device the reported ¿catheter (body/shaft)-separated in patient¿ could not be confirmed or further clarified.Procedural factors such as entrapment during an evar procedure may have contributed to the reported event.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿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.Avoid entrapment of the catheter between other endovascular devices and the vessel wall.Avoid excessive friction on the catheter; avoid simultaneous introduction of the catheter and aortic graft devices through the same sheath.¿ the use of 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, is contraindicated.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: CATH MB 5F PIG 110CM 6SH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16000419
• Report Number: 9616099-2022-06164
• Device Sequence Number: 5784170
• Product Code: DQO
• UDI-Device Identifier: 10705032012034
• UDI-Public: (01)10705032012034(17)250630(10)18127005
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K915836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2022

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: 06/30/2025
• Device Model Number: 532598B
• Device Catalogue Number: 532598B
• Device Lot Number: 18127005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 12/23/2022
• Date Device Manufactured: 07/12/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INDY OTW VASCULAR RETRIEVER SNARE; PHILIPS HIGH-PRESSURE; UNKNOWN HIGH-PRESSURE
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown