MAUDE Adverse Event Report: UNKSUPERTORQUEC; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 532X

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2021

Event Type  Injury  

Manufacturer Narrative

This is one of two reports submitted for the same event.Please reference mfr report #: 9616099-2021-04816.The product was not returned for analysis.The device history review (dhr) could not be completed as the lot number was not provided.The exact catalog number is unknown.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, after the limb of an aaa incraft device was installed, the device was removed; however, the ¿white olive tip¿ remained in the patient¿s body and the rest of the device was removed.The blood vessel had a lot of calcium and the angle was very severe, so it did not go up well even when the device was first raised using an unknown stiff wire.There was resistance/friction noted during pullback and during delivery system withdrawal.Before using the incraft device, an unknown cordis pigtail catheter was also cut/separated on the body/shaft.Resistance was met while advancing the pigtail catheter.Resistance met while advancing the pigtail catheter over the guidewire.Resistance was met while withdrawing the pigtail catheter.Images provided show the marker bands on the pigtail catheter offset/out of position.The separated segments were removed with a snare.This was a aaa endoleak repair procedure.The user was trained with the device.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The device was stored and handled according to the instructions for use (ifu).The device was inspected and prepped according to the ifu.This vessel was very calcified and tortuous.There were no damages to the devices noticed after opening the package.The sheath hemostasis valve screw cap was verified tight prior to use.There was no difficulty encountered flushing the guidewire lumen or the prosthesis lumen.Two non-cordis guidewires were used for ipsilateral access.The diagnostic catheter was withdrawn to a position just above the aortic bifurcation before the insertion of the incraft device.The diagnostic catheter was withdrawn over a guidewire.The delivery handle and delivery system shaft were parallel with the patient¿s leg during deployment.The bifurcate contralateral side marker was aligned with the contralateral iliac artery.The bifurcate expanded fully with good wall apposition.The outer sheath maintained a fixed position when removing the bifurcate delivery system.The position of the graft edge markers remained fixed while retracting the sheath.The limb prosthesis expanded fully with good apposition to the bifurcate legs.For the pigtail catheter, there were no anomalies noted during prep.Excessive torqueing was not required.The pigtail catheter did not kink in the area of separation.The devices will not be returned for evaluation as they were discarded in the hospital.

Manufacturer Narrative

This is one of two reports submitted for the same event.Please reference mfr report #: 9616099-2021-04816.Complaint conclusion: after the limb of an aaa incraft device was installed, the device was removed; however, the ¿white olive tip¿ remained in the patient¿s body and the rest of the device was removed.The blood vessel had a lot of calcium and the angle was very severe, so it did not go up well even when the device was first raised using an unknown stiff wire.There was resistance/friction noted during pullback and during delivery system withdrawal.Before using the incraft device, an unknown cordis pigtail catheter was also cut/separated on the body/shaft.Resistance was met while advancing the pigtail catheter.Resistance met while advancing the pigtail catheter over the guidewire.Resistance was met while withdrawing the pigtail catheter.Images provided show the marker bands on the pigtail catheter offset/out of position.The separated segments were removed with a snare.This was a aaa endoleak repair procedure.The user was trained with the device.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The device was stored and handled according to the instructions for use (ifu).The device was inspected and prepped according to the ifu.This vessel was very calcified and tortuous.There were no damages to the devices noticed after opening the package.The sheath hemostasis valve screw cap was verified tight prior to use.There was no difficulty encountered flushing the guidewire lumen or the prosthesis lumen.Two non-cordis guidewires were used for ipsilateral access.The diagnostic catheter was withdrawn to a position just above the aortic bifurcation before the insertion of the incraft device.The diagnostic catheter was withdrawn over a guidewire.The delivery handle and delivery system shaft were parallel with the patient¿s leg during deployment.The bifurcate contralateral side marker was aligned with the contralateral iliac artery.The bifurcate expanded fully with good wall apposition.The outer sheath maintained a fixed position when removing the bifurcate delivery system.The position of the graft edge markers remained fixed while retracting the sheath.The limb prosthesis expanded fully with good apposition to the bifurcate legs.For the pigtail catheter, there were no anomalies noted during prep.Excessive torqueing was not required.The pigtail catheter did not kink in the area of separation.The products were not returned for analysis.No lot number was provided therefore a product history record (phr) review could not be generated.The reported catheter (body/shaft) separated - in-patient¿, ¿marker band (supertorque) offset/out of position¿, ¿catheter (body/shaft) tracking difficulty¿, "catheter (body/shaft) - resistance/friction - in-patient", and "catheter (body/shaft) - withdrawal difficulty - from vessel" could not be confirmed as the devices were not returned for analysis.The exact cause could not be determined.Vessel characteristics of ¿a lot of calcium¿ and severe angulation may have contributed to the reported event.Although not intended as a mitigation of risk, 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), ¿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.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.Complications: movement of the marker bands along the catheter can result in inaccurate reference and device sizing.Dislodgement of the marker bands into the vascular system can result in additional intervention, embolism, thrombosis, or other vascular complications.Avoid excessive tension on the device during manipulation.Extreme care to avoid stretching or elongation must be exercised during manipulation and withdrawal.If resistance is felt during manipulation, determine the cause of resistance before proceeding and confirm.Supertorque® mb angiographic catheter positioning under high quality fluoroscopic observation.¿ the information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: UNKSUPERTORQUEC
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 12605756
• MDR Text Key: 280682911
• Report Number: 9616099-2021-04918
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K922891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 532X
• Device Catalogue Number: 532X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COOK LUNDERQUIST WIRE; TERUMO STIFF WIRE