MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 IM 55CM; CATHETER, PERCUTANEOUS

Model Number	67019055
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	09/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, a 6f.070 internal mammary (im) 55cm vista brite tip catheter became kinked inside the right iliac artery.The right iliac artery was quite tortuous, and the physician was having a difficult time cannulating the renal artery.After manipulation of the vista brite tip catheter, the catheter snapped off inside the iliac artery.At this time, the physician elected to use an 3.2f 4mmx8mm non-cordis, to attempt to remove the catheter.The catheter was snared, then pulled back into the 6fr 10 cm non-cordis sheath.The physician then attempted to remove the snapped off guide piece along with the 6fr 10 cm non-cordis sheath from the femoral artery.The catheter was pulled back into the common femoral artery but was unable to be removed from the body.At this time, the physician and a vascular surgeon decided it would be best to remove the catheter surgically.The patient was then transferred to surgery and the catheter was removed without incident.The patient was discharged the next day with no further complications.There was no reported patient injury.The physician was performing a diagnostic angiogram to assess the patient's renal arteries.The physician was using the vista brite catheter to cannulate the renal artery and used the right femoral artery for access.The device was stored, handled, and prepped according to the instructions for use (ifu).There were no anomalies noted when removed from the package nor were other damages noted prior to inserting the product the product into the patient.The device was discarded and will not be returned for evaluation.
Additional Manufacturer Narrative
The lot number is unknown; if received it will be provided.Complaint conclusion: as reported, a 6f.070 internal mammary (im) 55cm vista brite tip catheter became kinked inside the right iliac artery.The right iliac artery was quite tortuous, and the physician was having a difficult time cannulating the renal artery.After manipulation of the vista brite tip catheter, the catheter snapped off inside the iliac artery.At this time, the physician elected to use an 3.2f 4mmx8mm non-cordis, to attempt to remove the catheter.The catheter was snared, then pulled back into the 6fr 10 cm non-cordis sheath.The physician then attempted to remove the snapped off guide piece along with the 6fr 10 cm non-cordis sheath from the femoral artery.The catheter was pulled back into the common femoral artery but was unable to be removed from the body.At this time, the physician and a vascular surgeon decided it would be best to remove the catheter surgically.The patient was then transferred to surgery and the catheter was removed without incident.The patient was discharged the next day with no further complications.There was no reported patient injury.The physician was performing a diagnostic angiogram to assess the patient's renal arteries.The physician was using the vista brite catheter to cannulate the renal artery and used the right femoral artery for access.The device was stored, handled, and prepped according to the instructions for use (ifu).There were no anomalies noted when removed from the package nor were other damages noted prior to inserting the product the product into the patient.The product was not returned for analysis.The device lot number was not provided, as such a product history record (phr) could not be performed.Without the return of the device or images for analysis, the reported customer event ¿catheter (body/shaft)- separated - in-patient¿ could not be confirmed.Review of the information provided suggests that procedural factors such as excessive torquing of the catheter may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although 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.It also cautions that 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 cannot 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).¿ based on the information available there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: 6F .070 IM 55CM
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 15662929
• Report Number: 9616099-2022-06066
• Device Sequence Number: 16825461
• Product Code: DQY
• UDI-Device Identifier: 20705032020845
• UDI-Public: 20705032020845
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K021593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 67019055
• Device Catalogue Number: 67019055
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 10/24/2022
• 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: AMPLATZ GOOSE NECK 25MM; ENSNARE 3.2F 4MMX8MM,; TERUMO 6FR 10 CM PINNACLE SHEATH
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 78 KG