MAUDE Adverse Event Report: CORDIS CORPORATION CATH MB 5F PIG 65CM 8SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 532598C

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2022

Event Type  Injury  

Manufacturer Narrative

A product history record (phr) review of lot 18078272 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, while performing an endovascular aneurysm repair (evar) procedure on a female patient, the super torque marker band (mb) pigtail catheter (cath mb 5f pig 65cm 8sh) was placed for contrast injection purpose before the insertion of the main body device.The catheter was placed on a non-cordis stiff wire from the left femoral into a non-cordis sheath.The iliac artery was noted as heavily calcified.There was moderate vessel tortuosity, mild vessel angulation and no stenosis.The device was not used for a chronic total occlusion.When the physician attempted removal of the catheter, resistance was felt, and a decision was made to pull the catheter with the stiff wire together.When the distal part of the wire was pulled a few centimeters out they realized that the distal part of the catheter was missing.The distal part of the device with the marker bands separated.The distal part was detected under x-ray between the iliac and the aorta.The physician performed a contralateral snaring procedure and removed the separated part.There was no reported patient injury.The device was opened in a sterile field; it was also stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the instructions for use (ifu).There was no any difficulty experienced in prepping the device; no anomalies noted when the product was removed from the package and no anomalies noted during prep.The device was not resterilized.There was no resistance met while advancing the device.Unusual force was necessary when trying to pull the catheter out over the wire but when resistance was felt, the wire was removed.Excessive torquing was not required.The event caused a clinically relevant increase in the duration of the procedure; however, it did not cause a condition that required hospitalization or significant prolongation of existing hospitalization.A procedural cd is not available.

Manufacturer Narrative

As reported, while performing an endovascular aneurysm repair (evar) procedure on a female patient, the super torque marker band (mb) pigtail catheter (cath mb 5f pig 65cm 8sh) was placed for contrast injection purpose before the insertion of the main body device.The catheter was placed on a non-cordis stiff wire from the left femoral into a non-cordis sheath.The iliac artery was noted as heavily calcified.There was moderate vessel tortuosity, mild vessel angulation and no stenosis.The device was not used for a chronic total occlusion.When the physician attempted removal of the catheter, resistance was felt, and a decision was made to pull the catheter with the stiff wire together.When the distal part of the wire was pulled a few centimeters out they realized that the distal part of the catheter was missing.The distal part of the device with the marker bands separated.The distal part was detected under x-ray between the iliac and the aorta.The physician performed a contralateral snaring procedure and removed the separated part.There was no reported patient injury.The device was opened in a sterile field; it was also stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device; no anomalies noted when the product was removed from the package and no anomalies noted during prep.The device was not resterilized.There was no resistance met while advancing the device.Unusual force was necessary when trying to pull the catheter out over the wire but when resistance was felt, the wire was removed.Excessive torquing was not required.The event caused a clinically relevant increase in the duration of the procedure; however, it did not cause a condition that required hospitalization or significant prolongation of existing hospitalization.One non-sterile cath mb 5f pig 65cm 8sh unit was received for analysis.During visual inspection, the marker bands on the device were observed moved/out of position, the unit presented five out of the twenty marker bands moved/out of position at the proximal section.Additionally, a separated condition was noted approximately 25.5 cm from the distal tip.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Functional analysis could not be performed due the separated condition of the unit.For microscopic analysis, an amplified image of the moved marker bands was taken.No anomalies were observed.Sem analysis presented evidence of elongations on the body/shaft material of the unit and a scratch mark near the separated area.A product history record (phr) review of lot 18078272 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The event reported by the customer as ¿catheter (body/shaft) ¿ resistance/friction - in patient¿ was not confirmed.Functional analysis could not be performed due the separated condition.The reported event, ¿catheter (body/shaft) ¿ separated - in-patient¿ was confirmed.A separated condition was noted on the unit.The elongations found on the body/shaft are commonly associated with separations caused by material tensile overload.Therefore, it is assumed the body/shaft of the catheter was induced to a tensile force that exceeded its yield strength prior to the separation.Additionally, the scratch marks near separation suggest the unit was torn by exposure to a sharp object.During visual analysis marker bands were found offset/out of position, which is caused by elongation of the catheter.The exact cause of these findings cannot be conclusively determined with the available information.Vessel characteristics (tortuosity, calcified plaque) and/or procedural factors may have contributed to the reported event.When resistance is met, the operator should take great care before applying more force during withdrawal.Magnified fluoroscopy will usually identify the point/ source of resistance.Often advancing the catheter rather retraction can resolve the issue.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.¿ 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 65CM 8SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 14463241
• MDR Text Key: 292349176
• Report Number: 9616099-2022-05649
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032012041
• UDI-Public: 10705032012041
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 532598C
• Device Catalogue Number: 532598C
• Device Lot Number: 18078272
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• 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: STIFF COOK WIRELUNDERQUIST 260 CM J TIP,14F GO
• Patient Outcome(s): Life Threatening
• Patient Sex: Female
• Patient Weight: 75 KG