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

Model Number 532598B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2020

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17872108 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, a 5f 100cm 6 side holes (6sh) super torque marker bands (mb) diagnostic catheter ¿tore off¿ during removal.Therefore, it could not be recovered ¿in toto¿.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections b5,g4,g7 and h2 have been updated accordingly.Section b5:addendum for additional information returned: the user could not remove part of the catheter; it remains in the patient.The device was stored in the catheter cabinet.The device was stored, handled and prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.There was no anomaly noted prior to inserting the device into the patient.There was no damage noted to the device prior to opening the package.There was no difficulty removing the device from the sterile packaging.There was no excess force used but there was a slight resistance while pulling back, the catheter was stiff over the wire.The target was infrarenal aneurysm.There was little to moderate calcification.There was severe tortuosity in the pelvic artery.There was no stenosis and the device was not used for a chronic total occlusion.The part of the catheter tore on the wire and the remaining part in the patient was fixed between the stent and the vessel wall.The patient was released home, without any complaints.Image analysis: five jpg images of a monitor screen were provided for review.Image 1: this shows a likely evar procedure with a wired diagnostic catheter with marker bands exiting a sheath with a radiopaque tip in the right common iliac artery accessing the aorta, and a wire accessing the aorta via the left common iliac artery.Image 2: this shows a diagnostic catheter (dc) with marker band (mb) and a wire as above but within the pelvic girdle.The dc has been separated in the iliac artery and a large french sheath is distal to the separated dc and a wire is within the sheath.The bilateral iliac arteries appear to be very tortuous.Image 3: this shows a scenario similar to above except the wire in the sheath has been withdrawn and the right iliac artery is illuminated with radiopaque contrast.Image 4: this shows the separated dc, which can now be determined to be a pigtail catheter, has been ¿jailed¿ behind the stent grafts of the evar device.The stent grafts appear to have been successfully deployed.Image 5: this shows a digital subtraction image illustrating a successful deployment of the evar device with excellent flow.The ¿jailed¿ pigtail catheter remains present but behind the evar device.Additional information is pending and will be sent in upon 30 days after receipt.

Manufacturer Narrative

The device has been returned for evaluation, but the manufacture report is not yet available.Additional information is pending and will be sent in upon 30 days after receipt.

Manufacturer Narrative

As reported, a 5f 100cm 6 side holes (6sh) super torque marker bands (mb) diagnostic catheter tore off during removal.The user could not remove part of the catheter; it remains in the patient.There was no excess force used but there was a slight resistance while pulling back, the catheter was stiff over the wire.A second (6sh) super torque was returned and it was observed that the marker bands on the device were observed moved/out of position, presenting twelve out of the twenty marker bands moved/out of position at the distal section of the unit.The device was stored in the catheter cabinet.The device was stored, handled and prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.There was no anomaly noted prior to inserting the device into the patient.There was no damage noted to the device prior to opening the package.There was no difficulty removing the device from the sterile packaging.The target was infrarenal aneurysm.There was little to moderate calcification.There was severe tortuosity in the pelvic artery.There was no stenosis and the device was not used for a chronic total occlusion.The part of the catheter tore on the wire and the remaining part in the patient was fixed between the stent and the vessel wall.The patient was released home, without any complaints.Five jpg images of a monitor screen were provided for review.Image 1: this shows a likely evar procedure with a wired diagnostic catheter with marker bands exiting a sheath with a radiopaque tip in the right common iliac artery accessing the aorta, and a wire accessing the aorta via the left common iliac artery.Image 2: this shows a diagnostic catheter (dc) with marker band (mb) and a wire as above but within the pelvic girdle.The dc has been separated in the iliac artery and a large french sheath is distal to the separated dc and a wire is within the sheath.The bilateral iliac arteries appear to be very tortuous.Image 3: this shows a scenario similar to above except the wire in the sheath has been withdrawn and the right iliac artery is illuminated with radiopaque contrast.Image 4: this shows the separated dc, which can now be determined to be a pigtail catheter, has been ¿jailed¿ behind the stent grafts of the evar device.The stent grafts appear to have been successfully deployed.Image 5: this shows a digital subtraction image illustrating a successful deployment of the evar device with excellent flow.The ¿jailed¿ pigtail catheter remains present but behind the evar device.Two non-sterile super torque marker bands (mb) diagnostic catheter (cath mb 5f pig 110cm 6sh) units were received for analysis.The first device is evaluated under 2020-00124167-1, and the second device will be evaluated under 2020-00124167-2.The second device is pending analysis.A product history record (phr) review of lot 17872108 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Per visual analysis, a separated condition was found at the height of the first marker band from the hub.No other anomalies were observed during the analysis.Sem analysis was performed, and the results showed the separated area of the body/shaft of super torque mb diagnostic catheter presented evidence of elongations and cup and transferred material on the body/shaft material.No other anomalies were observed.The transferred material observed on body/shaft suggests that the material fusion was achieved.In addition, the elongations and the transferred material found on the body/shaft material are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body/shaft material was induced to a tensile force that exceeded the body/shaft material yield strength prior to the separation.No other anomalies were observed during sem analysis.For the first complaint device, the reported event by the customer as ¿catheter (body/shaft) ¿ resistance/friction - in-patient¿ was not confirmed since functional test could not be performed due the separated condition.The reported event by the customer as ¿catheter (body/shaft) ¿ separated - in-patient¿ was confirmed since a separated condition was found on the body during visual inspection.Per sem analysis, it is assumed that the body/shaft material was induced to a tensile force that exceeded the body/shaft material yield strength prior to the separation.Procedural/handling factors or vessel characteristics (severe tortuosity, calcification) might have contributed to the reported conditions.Per the instructions for use (ifu), which is 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.Avoid entrapment of the catheter between other endovascular devices and the vessel wall.Avoid excessive friction on the catheter; avoid simultaneous introduction of the catheter and aortic graft devices through the same sheath.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.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.Extreme care to avoid stretching or elongation must be exercised during manipulation and withdrawal.¿ the phr review nor the first product analysis suggests that the reported failures could be related to the manufacturing process of the unit.The second device evaluation is ongoing and the conclusion will be updated pending the final results.

• Brand Name: CATH MB 5F PIG 110CM 6SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10502864
• MDR Text Key: 205943988
• Report Number: 9616099-2020-03888
• 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,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 532598B
• Device Catalogue Number: 532598B
• Device Lot Number: 17872108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 09/11/2020; 10/21/2020; 12/10/2020
• Supplement Dates FDA Received: 10/06/2020; 11/16/2020; 01/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2019
• 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