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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.

• Brand Name: CATH MB 5F PIG 65CM 8SH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11028055
• Report Number: 9616099-2020-04132
• Device Sequence Number: 11649830
• Product Code: DQO
• UDI-Device Identifier: 10705032012041
• UDI-Public: 10705032012041
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K915836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 532598C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 12/27/2020
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 12/30/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK WIRE; UNK WIRE
• Outcome Attributed to Adverse Event: Required Intervention