MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO 244 S DE RL DE CV CATH MB 5F PIG 110CM 6SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problems Difficult to Remove (1528); Separation Failure (2547)

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

Event Date 11/03/2021

Event Type  malfunction  

Event Description

While trying to take out a 5f 110cm supertorque marker band pigtail catheter out over a non-cordis wire, the physician experienced friction and pulled the catheter with a bit more force when it came out lacking the distal part of the catheter (all the parts with the marker band were missing).The non-cordis sheath was pulled out of the artery and the distal part of the catheter was found in the common femoral where the initial incision took place and (where) the sheath was placed.The catheter was pulled out manually and the procedure went on.Once again, a new 12 f non-cordis sheath was placed over the stiff wire and once again a new 5f 110cm supertorque marker band catheter pigtail catheter was placed.Contrast was injected and the length was measured, when trying to take out the catheter the doctor felt friction once again.While pulling with more force he was able to take the catheter out with out the distal part once again.There was no reported patient injury.The devices were used in an endovascular treatment of abdominal aortic aneurysms (evar).The catheter was placed over a non-cordis extra stiff guidewire and then contrast was injected through the sheath to measure the length of the limb extension needed.After measuring the length, the device was attempted to be removed.The lot numbers are not available because the devices and their packaging were not saved.

Manufacturer Narrative

(b)(6).Product history review could not be performed since complaint lot is unknown.This is one of two devices associated with the reported event but the related number is not yet available but will be provided when the second report is submitted.

Manufacturer Narrative

Additional b5 narrative: the distal distal part of the second catheter was in the patients femora artery (just like the first) and was removed like the first one, pulled out manually.The access site was the common femoral.The procedure was for aortic abdominal aneurysm.There were no anomalies noted when either catheter was removed from the package and no anomalies noted during prep of either device.The devices were not inserted through a stopcock instead of a hemostatic valve.There was no resistance met while advancing either device over the guidewire.The devices did not kink in the area of separation which was 10-15cm from the distal end.The procedure was completed and there was no patient injury.The patient was well at the end to procedure.No additional patient information was available.It is not yet known if procedural films are available.This is one of two devices associated with the event and the related report number is 9616099-2021-05075.

Manufacturer Narrative

While trying to withdraw a 5f 110cm supertorque marker band pigtail catheter over a non-cordis wire, the physician experienced friction and pulled the catheter with a bit more force when it came out lacking the distal part of the catheter (all the parts with the marker band were missing).The non-cordis sheath was pulled out of the artery and the distal part of the catheter was found in the common femoral where the initial incision took place and (where) the sheath was placed.The catheter was pulled out manually and the procedure went on.Once again, a new 12 f non-cordis sheath was placed over the stiff wire and once again a new 5f 110cm supertorque marker band catheter pigtail catheter was placed.Contrast was injected and the length was measured, when trying to take out the catheter the doctor felt friction once again.While pulling with more force he was able to take the catheter out without the distal part once again, and it was removed like the first one, pulled out manually.There was no reported patient injury.The devices were used in in an endovascular treatment of abdominal aortic aneurysms (evar).The access site was the common femoral.There were no anomalies noted when either catheter was removed from the package and no anomalies noted during prep of either device.The devices were not inserted through a stopcock instead of a hemostatic valve.There was no resistance met while advancing either device over the guidewire.The catheter was placed over a non-cordis extra stiff guidewire and then contrast was injected through the sheath to measure the length of the limb extension needed.After measuring the length, the device was attempted to be removed.The devices did not kink in the area of the separation which was 10-15cm from the distal end.The procedure was completed.The patient was well at the end to procedure.The lot numbers are not available because the devices and their packaging were not saved.The devices were not returned for evaluation and lot numbers were not provided.Therefore, a product analysis or product history record (phr) review could not be performed.Without the return of the device or images for analysis, the reported customer events ¿catheter (body/shaft) ¿ withdrawal difficulty¿ and ¿brite tip/distal tip-separated in-patient¿ could not be confirmed.Procedural/handling factors such as entrapment of the catheter between other endovascular devices and the vessel wall may have contributed to this issue.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 the catheter and dislodge into the vascular system.Avoid entrapment of the catheter between other endovascular devices and the vessel wall.¿ 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.This is one of two devices associated with the event and the related report number is 9616099-2021-05075.

• Brand Name: CATH MB 5F PIG 110CM 6SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CARDINAL HEALTH MEXICO 244 S DE RL DE CV; santiago troncoso 808; juarez 32574 ; MX 32574
• Manufacturer (Section G): CARDINAL HEALTH MEXICO 244 S DE RL DE CV; santiago troncoso 808; juarez 32574 ; MX 32574
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12866163
• MDR Text Key: 283108778
• Report Number: 9616099-2021-05074
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 532598B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• 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: LUNDERQUIST® EXTRA-STIFF WIRE GUIDE, 12F GORE SHEA
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 90 KG