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

Model Number 532598B

Device Problem Difficult to Remove (1528)

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

Event Date 01/31/2022

Event Type  malfunction  

Event Description

As reported, the 5f 110cm mb super torque catheter was in the iliac artery; however, upon attempting to retract the catheter he felt resistance between the catheter and unknown 8f sheath.Once the catheter was removed, the physician noted the calibration markings had moved.It was also noted that none of the markers appeared to have come off the catheter.There was no reported injury to the patient.The physician was experienced with using the marking pigtail.There was no damaged to the packaging of the device.The product was stored per the instruction for use (ifu), hanging behind glass doors.The device was prepped per the ifu.There was no resistance/friction while advancing the catheter through the sheath.The catheter was not being used to treat a chronic total occlusion (cto).The device was confirmed to be inserted through a rotating hemostatic valve.The damage happened after the imaging and calibration of the evar was completed successfully no other product needed to be used.The physician speculates the malfunction could have been caused by the vessel disease as the access site was noted to be calcified.The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18030194 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 5f 110cm mb super torque catheter was in the iliac artery; however, upon attempting to retract the catheter he felt resistance between the catheter and unknown 8f sheath.Once the catheter was removed, the physician noted the calibration markings had moved.It was also noted that none of the markers appeared to have come off the catheter.There was no reported injury to the patient.The physician was experienced with using the marking pigtail.There was no damaged to the packaging of the device.The product was stored per the instruction for use (ifu), hanging behind glass doors.The device was prepped per the ifu.There was no resistance/friction while advancing the catheter through the sheath.The catheter was not being used to treat a chronic total occlusion (cto).The device was confirmed to be inserted through a rotating hemostatic valve.The damage happened after the imaging and calibration of the evar was completed successfully no other product needed to be used.The physician speculates the malfunction could have been caused by the vessel disease as the access site was noted to be calcified.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, d9, g3, h1, h2, h3 and h6 additional information is pending and will be submitted within 30 days upon receipt.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, the 5f 110cm mb super torque catheter was in the iliac artery; however, upon attempting to retract the catheter he felt resistance between the catheter and unknown 8f sheath.Once the catheter was removed, the physician noted the calibration markings had moved.It was also noted that none of the markers appeared to have come off the catheter.There was no reported injury to the patient.The physician was experienced with using the marking pigtail.There was no damaged to the packaging of the device.The product was stored per the instruction for use (ifu), hanging behind glass doors.The device was prepped per the ifu.There was no resistance/friction while advancing the catheter through the sheath.The catheter was not being used to treat a chronic total occlusion (cto).The device was confirmed to be inserted through a rotating hemostatic valve.The damage happened after the imaging and calibration of the evar was completed successfully no other product needed to be used.The physician speculates the malfunction could have been caused by the vessel disease as the access site was noted to be calcified.The device will be returned for evaluation.

Manufacturer Narrative

As reported, the 5f 110cm supertorque mb catheter was in the iliac artery; however, upon attempting to retract the catheter, the user felt resistance between the catheter and the unknown 8f sheath.Once the catheter was removed, the physician noted the calibration markings had moved.It was also noted that none of the markers appeared to have come off the catheter.There was no reported injury.The physician was experienced with using the marking pigtail catheter.There were no damages to the packaging of the device.The product was stored per the instruction for use (ifu), hanging behind glass doors.The device was prepped per the ifu.There was no resistance/friction while advancing the catheter through the sheath.The catheter was not being used to treat a chronic total occlusion (cto).The device was confirmed to be inserted through a rotating hemostatic valve.The damage happened after the imaging and calibration of the endovascular aneurysm repair (evar) procedure was completed successfully, no other product needed to be used.The physician speculates the malfunction could have been caused by the vessel disease as the access site was noted to be calcified.A non-sterile unit of product ¿cath mb 5f pig 110cm 6sh¿ was received for analysis.Per visual analysis, it was observed that 14 marker bands, from the number 7 to number 20 were moved from their original position (the position of the marker bands is numerated from the distal end to the hub).All marker bands were present on the catheter body, none were missing.No other damages or anomalies were found.The dimensions of the inner diameter (id) and outer diameter (od) on the body shaft were measured at the area located between the assigned places for markers bands that are offset/out of position.The dimensional analysis results were found out of specification due to the elongated condition observed on the returned product.Per functional analysis, a 0.038¿ lab sample guidewire was inserted inside the catheter via distal tip.The guide wire went through the catheter without difficulties.Insertion/withdrawal was also performed also without difficulty through a lab sample 5f catheter sheath introducer (csi).Per microscopic analysis, it was observed that the marker band marks on unit¿s surface did not present evidence of damage (scratches, peelings, abrasions, etc.).No other issues were noted during microscopic analysis.A product history record (phr) review of lot 18030194 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft) withdrawal difficulty¿ was not confirmed since the device passed functional analysis with a lab sample csi.However, the event reported by the customer as ¿marker band (supertorque) offset/out of position¿ was confirmed through analysis of the returned device.The exact cause of this condition could not be conclusively determined during analysis.Based on the information available for review, vessel characteristics (physician speculates that access site calcification may have caused the issue) and procedural/handling factors likely contributed to the offset/out of position marker bands and subsequent withdrawal difficulty as evidenced by the presence of elongations noted in the catheter.Although not intended as a mitigation of risk, the information for safety within the ifu is provided in the products labeling with the intent to make the user aware of the risks.According to the ifu, users are warned that ¿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.¿ neither the phr review nor the product analysis suggest that the events experienced by the customer could be related to the manufacturing process of the unit.Additionally, no anomalies were found when reviewing the manufacturing process flow and the verification controls.Therefore, no corrective/preventive action will be taken at this time.

• Brand Name: CATH MB 5F PIG 110CM 6SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13592989
• MDR Text Key: 286529681
• Report Number: 9616099-2022-05369
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032012031
• UDI-Public: (01)20705032012031(17)240531(10)18030194
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 532598B
• Device Catalogue Number: 532598B
• Device Lot Number: 18030194
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• 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 8F SHEATH.