MAUDE Adverse Event Report: CORDIS US. CORP SUPER TORQUE MB; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 532598B

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  Injury  

Event Description

As reported, two 5f 100cm supertorque markerband pig catheters teared apart and had to be burdened in the patient.The procedure was completed by getting rid of the ruptured part via pta balloon into a large csi.The separated pieces were removed with a snare.This occurred during and evar procedure.The device was stored by hanging in a cupboard.There was no damage to the packaging.There was no damage noted while taking the device out.The device was prepped per the instructions for use (ifu).There were no difficulties noted during prep.There was no resistance noted while pushing through the 14f non-cordis csi.There were no difficulties while entering the vessel.The lesion was noted to have a little calcification.The vessel was noted to have an average amount of tortuosity.There was no resistance at will with both catheters during withdrawal.The catheters were not jailed.The devices will not be returned for evaluation.

Manufacturer Narrative

Without a lot number to conduct a device history record (dhr) review, it is not possible to determine if the reported failure could be related to the manufacturing process.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, two 5f 100cm supertorque markerband pig catheters teared apart and had to be burdened in the patient.The procedure was completed by getting rid of the ruptured part via pta balloon into a large csi.The separated pieces were removed with a snare.This occurred during and evar procedure.The device was stored by hanging in a cupboard.There was no damage to the packaging.There was no damage noted while taking the device out.The device was prepped per the instructions for use (ifu).There were no difficulties noted during prep.There was no resistance noted while pushing through the 14f non-cordis csi.There were no difficulties while entering the vessel.The lesion was noted to have a little calcification.The vessel was noted to have an average amount of tortuosity.There was no resistance at will with both catheters during withdrawal.The catheters were not jailed.The devices will not be returned for evaluation.Two pictures related to the reported failure were attached.The pictures # 1& 2 show the catheter in two pieces.

Manufacturer Narrative

As reported, two 5f 100cm supertorque markerband pig catheters tore apart and had to be burdened in the patient.The procedure was completed by getting rid of the ruptured part via pta balloon into a large csi.The separated pieces were removed with a snare.This occurred during and evar procedure.The device was stored by hanging in a cupboard.There was no damage to the packaging.There was no damage noted while taking the device out.The device was prepped per the instructions for use (ifu).There were no difficulties noted during prep.There was no resistance noted while pushing through the 14f non-cordis csi.There were no difficulties while entering the vessel.The lesion was noted to have a little calcification.The vessel was noted to have an average amount of tortuosity.There was no resistance at will with both catheters during withdrawal.The catheters were not jailed.Two images were provided for analysis.Both show a catheter separated in two pieces.No other anomalies were noted during the image review.A product history record (phr) review could not be performed for either device because the lot numbers are unknown.The complaints reported by the customer ¿catheter (body/shaft)-separated ¿was confirmed by image analysis for both devices/complaints.Without the return of the device, the exact cause of the reported event cannot be conclusively determined.Handling factors such as excessive manipulation of the catheter, which led to material tensile overload is a potential cause.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, ¿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 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.Super torque® mb angiographic catheter positioning under high quality fluoroscopic observation.¿ 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.

• Brand Name: SUPER TORQUE MB
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US. CORP; 14201 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: 17632709
• MDR Text Key: 322071607
• Report Number: 9616099-2023-06588
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 532598B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: UNKNOWN.
• Patient Outcome(s): Life Threatening; Other