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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CATH MB 5F PIG 65CM 8SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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CATH MB 5F PIG 65CM 8SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number N/A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/20/2020
Event Type  Injury  
Manufacturer Narrative
A review of the manufacturing records could not be conducted without a lot number.The device was returned and the completed engineering report will be submitted within 30 days upon receipt.
 
Event Description
There was moderate resistance while withdrawing a 5f 65cm pigtail (pig) super torque diagnostic catheter from a patient and the tip broke off inside the patient¿s aorta during removal over an unknown wire.The device separated at 20cm from the distal end and the catheter tip was retrieved from the patient with a snare.The procedure being performed was a aaa repair with endograft placement.The access site was the left common femoral artery.It was not a chronic total occlusion (cto).There was moderate iliac artery tortuosity and moderate vessel take off.The device was stored as per labeling and opened in sterile field.There were no anomalies noted when removed from the package and no anomalies noted during prep.There was no resistance met while advancing the device.Procedural films were requested but were not available.There was no patient harm.Additional patient and procedural details were requested but were not available.The lot number is also not available as the packaging was discarded by the user.
 
Manufacturer Narrative
There was moderate resistance while withdrawing a 5f 65cm pigtail (pig) super torque diagnostic catheter from a patient and the tip broke off inside the patient¿s aorta during removal over an unknown wire.The device separated at 20cm from the distal end and the catheter tip was retrieved from the patient with a snare.The procedure being performed was a aaa repair with endograft placement.The access site was the left common femoral artery.It was not a chronic total occlusion (cto).There was moderate iliac artery tortuosity and moderate vessel take off.The device was stored as per labeling and opened in sterile field.There were no anomalies noted when removed from the package and no anomalies noted during prep.There was no resistance met while advancing the device.Procedural films were requested but were not available.There was no patient harm.One non-sterile unit of a super torque mb diagnostic catheter (cath mb 5f pig 65cm 8sh) was received for analysis.Per visual analysis, the tip of the unit was observed separated at 24.8 cm from the distal end.No other anomalies were found.Per microscopic analysis, the device was sent to sem analysis to determine the root cause of the separated condition.Sem results showed that the observed separated tip area presented a pattern that shows evidence of material elongations and material transferred.The elongations found on the separated tip and the material transferred observed are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the tip separation was induced due to a tensile force that exceeded the tip material yield strength prior to the separation.No other issues were noted during sem analysis.Per dimensional analysis, the outer diameter (od) and inner diameter (id) of the unit were measured near the separated area and the results were found within specification.As the sterile lot number was not available, product history record (phr) reviews could not be performed.The reported event by the customer as ¿brite tip/distal tip ¿ catheters- separated - in-patient¿ was confirmed due to the separated tip condition of the unit as received.However, the reported event by the customer as ¿catheter (body/shaft)- resistance/friction - in-patient¿ could not be evaluated due to the nature of the reported complaint itself.The cause of the separated tip condition of the unit could not be conclusively determined, however the returned product presented evidence that the device was induced due to a tensile force that exceeded the tip material yield strength prior to the separation.Procedural (aaa repair with endograft placement) and handling factors might have contributed to the observed separated condition on the unit since the device did not present any obvious indication of manufacturing defect or anomaly that could contribute to the event as reported.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.¿ without a lot number to conduct a phr review and based on the results of the product analysis, there are no indications that the reported complaint is related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.
 
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Brand Name
CATH MB 5F PIG 65CM 8SH
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
MDR Report Key11028055
MDR Text Key222056156
Report Number9616099-2020-04132
Device Sequence Number1
Product Code DQO
UDI-Device Identifier10705032012041
UDI-Public10705032012041
Combination Product (y/n)N
PMA/PMN Number
K915836
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number532598C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2020
Initial Date Manufacturer Received 11/24/2020
Initial Date FDA Received12/17/2020
Supplement Dates Manufacturer Received12/27/2020
Supplement Dates FDA Received12/30/2020
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 Number1
Treatment
UNK WIRE; UNK WIRE
Patient Outcome(s) Required Intervention;
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