MAUDE Adverse Event Report: CORDIS CORPORATION 6F .072 H-STICK 100CM; CATHETER, PERCUTANEOUS

Model Number	67227800
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number to conduct a device history record (dhr) review, it is not possible to determine if the reported failure could be related to the manufacturing process.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 6f.072¿ 100cm hockey stick (h-stick) adroit guiding catheter got stuck inside a patient.The patient¿s groin was very tortuous and the adroit coiled up and will not come out.The patient was taken into surgery where a cut down was performed to remove the guiding catheter.The device was stored and handled as per the instruction for use (ifu).There was no damage noted to the packaging of the device nor were there anomalies noted when removed from the package.There were no kinks or other damages noted prior to inserting the product the product into the patient.The device was prepped according to the ifu.The intended procedure/target lesion was left heart cath.Vessel tortuosity was moderate to severe.The device was not resterilized.The current patient of the patient is stable.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
As reported, a 6f.072¿ 100cm hockey stick (h-stick) adroit guiding catheter got stuck inside a patient.The patient¿s groin was very tortuous and the adroit coiled up and will not come out.The patient was taken into surgery where a cut down was performed to remove the guiding catheter.The device was stored and handled as per the instruction for use (ifu).There was no damage noted to the packaging of the device nor were there anomalies noted when removed from the package.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped according to the ifu.The intended procedure/target lesion was left heart cath.Vessel tortuosity was moderate to severe.The device was not resterilized.The current patient of the patient is stable.The device was not returned for evaluation.A product history record (phr) review of lot 17854931 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Based on the information provided, it is not possible to draw a clinical conclusion between the device and the reported event.Without the return of the device for analysis, the reported customer event ¿catheter (body/shaft) - withdrawal difficulty - from vessel¿ could not be confirmed and the exact root cause could not be determined.Procedural/handling factors or vessel characteristics (moderate to severe tortuosity) may have contributed to the reported event.According to the ifu, which is not intended as a mitigation of risk, ¿inspect the guiding catheter before use to verify that its size, shape and condition are suitable for the specific procedure.If strong resistance is met during manipulation, discontinue the procedure and determine the cause of the resistance before proceeding.If the cause of the resistance can not be determined, withdraw the catheter.Torquing the guiding catheter excessively while kinked may cause damage which could result in possible separation along the catheter shaft.Should the guiding catheter shaft become severely kinked, withdraw the entire system (guiding catheter, guidewire and catheter sheath introducer).Advancement, manipulation and withdrawal of the guiding catheter should always be performed under fluoroscopic guidance.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: 6F .072 H-STICK 100CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12026309
• Report Number: 9616099-2021-04649
• Device Sequence Number: 3388489
• Product Code: DQY
• UDI-Device Identifier: 20705032065372
• UDI-Public: 20705032065372
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 07/14/2021

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 Expiration Date: 03/31/2022
• Device Model Number: 67227800
• Device Catalogue Number: 67027800
• Device Lot Number: 17854931
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 06/27/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention