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

Model Number N/A

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant devices: wire: terumo 0,035 et lunderquist 260cm standard.Sheath introducer: gore dryseal 24fr et cook check flo 24 fr.This device is available for analysis but has not yet been received.Instead 2 pictures related to the reported failure were evaluated.As part of the pictures can be observed the distal part of the catheter and marked bands can be seen moved from original position.Blood residues can be noticed along the unit.No other anomalies can be noticed as part of the attached pictures.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.The complaints reported by the customer as ¿catheter- separated in patient & marker band (supertorque)- offset/out of position¿ were confirmed.The failure reported as ¿catheter-withdrawal difficulty¿ could no be confirmed as part of picture analysis.The root cause of these conditions could not be conclusively determined during the analysis of the received pictures; therefore, it is not possible to establish whether it is related to the manufacturing process of the product.Although the picture analysis suggests that failure reported is confirmed, no corrective or preventive actions will be taken at this time until the product is received to proceed with a complete evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

There was resistance when removing a 5f 110cm supertorque diagnostic catheter with 6 side holes (sh) which required excessive force and the supertorque catheter was cut in half.Twenty (20) centimeters of the diagnostic catheter remained in the patient.In addition, the radiopaque part moved along the diagnostic catheter.The surgeon succeeded in removing the second part that remained in the patient by using a non cordis-guidewire.The device was extracted entirely, in two pieces.The patient is doing "ok." the intended procedure was a complex aortic stenting of an aortic aneurysm.Access was via the femoral.There was calcification, weak angulation with mild to 0% stenosis.There were no anomalies noted when the device was removed from the package or during prep.There was no resistance met while advancing the device and no excessive torquing was required.There was also no resistance met while advancing the device over the guidewire.The device did not kink in the area of separation.Procedural films and patient demographics including medical history and the reason for the procedure were requested but are not available.The event caused a clinically relevant increase in the duration of the procedure but not significant prolongation of the existing hospitalization.The device will be returned for analysis.

Manufacturer Narrative

Additional b5 narrative: the procedure was not an evar.All of the marker bands were present on the catheter when removed from the patient.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

There was resistance when removing a 5f 110cm supertorque diagnostic catheter with 6 side holes (sh) which required excessive force and the supertorque catheter was cut in half.Twenty (20) centimeters of the diagnostic catheter remained in the patient.In addition, the radiopaque part moved along the diagnostic catheter.The surgeon succeeded in removing the second part that remained in the patient by using a non cordis-guidewire.The device was extracted entirely, in two pieces.All of the marker bands were present on the catheter when removed from the patient.The patient is doing "ok." the intended procedure was a complex aortic stenting of an aortic aneurysm.Access was via the femoral.There was calcification, weak angulation with mild to 0% stenosis.There were no anomalies noted when the device was removed from the package or during prep.There was no resistance met while advancing the device and no excessive torquing was required.There was also no resistance met while advancing the device over the guidewire.The device did not kink in the area of separation.Procedural films and patient demographics including medical history and the reason for the procedure were requested but are not available.The event caused a clinically relevant increase in the duration of the procedure but not significant prolongation of the existing hospitalization.The procedure was not an evar.No product was received for analysis, instead 2 pictures related to the reported failure were attached by the customer.Per visual analysis of the pictures, the distal part of the catheter and marker bands can be seen moved from original position.Blood residues can be noticed along the unit.No other anomalies can be noticed on the attached pictures.A product history record (phr) review of lot 17945369 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaints reported by the customer as ¿catheter- separated-in patient¿ & ¿marker band (supertorque)- offset/out of position¿ were confirmed via picture analysis.However, without the return of the device or procedural films, the exact root cause could not be determined.The failure reported as ¿catheter-withdrawal difficulty¿ could not be confirmed as part of picture analysis and due to the nature of the complaint.Procedural/handling factors (complex aortic stenting) or vessel characteristics (calcification) may have contributed to the reported event.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿failure to observe these instructions may result in damage, breakage, or separation of the catheter or the markerbands, which may necessitate additional intervention.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.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.¿ neither the phr review nor the picture analysis suggests that the found conditions could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: CATH MB 5F PIG 110CM 6SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10726265
• MDR Text Key: 212721766
• Report Number: 9616099-2020-04003
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032012034
• UDI-Public: 10705032012034
• Combination Product (y/n): N
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 532598B
• Device Lot Number: 17945369
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2020
• 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
• Patient Outcome(s): Required Intervention