MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F BER II 65CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 451415V0

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2021

Event Type  Injury  

Event Description

As reported, during a peripheral angiogram the tip of a 4f tempo ber ii 65cm guiding catheter came off in the patient.The tip was captured and retrieved with a wire.No injury was reported to the patient.The product was stored and handled according to the instructions for use.The device was not resterilized.The patient was listed in stable condition, and the procedure was completed as normal.A physician¿s dictated summary and procedure log is available.The device is being returned for evaluation.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, during a peripheral angiogram the tip of a 4f tempo ber ii 65cm guiding catheter came off in the patient.The tip was captured and retrieved with a wire.No injury was reported to the patient.The product was stored and handled according to the instructions for use.The device was not resterilized.The patient was listed in stable condition, and the procedure was completed as normal.The products were not returned for analysis however, it was reported both affected devices share the same lot number.A product history record (phr) review of lot 18022275 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer event ¿marker band (supertorque)- offset/out of position¿ could not be confirmed.Procedural/handling factors 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, ¿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.Stretching or elongation of the catheter during endovascular procedures could result in the marker bands moving along the catheter.In extreme cases, marker bands may come off.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.Complications: movement of the marker bands along the catheter can result in inaccurate reference and device sizing.Dislodgement of the marker bands into the vascular system can result in additional intervention, embolism, thrombosis, or other vascular complications.Avoid excessive tension on the device during manipulation.Extreme care to avoid stretching or elongation must be exercised during manipulation and withdrawal.If resistance is felt during manipulation, determine the cause of resistance before proceeding and confirm.Supertorque® mb angiographic catheter positioning under high quality fluoroscopic observation¿ based on the information available and the phr review, 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: CATH TEMPO 4F BER II 65CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13237979
• MDR Text Key: 286752545
• Report Number: 9616099-2022-05292
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 451415V0
• Device Lot Number: 18022275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• 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
• Treatment: UNKNOWN WIRE
• Patient Outcome(s): Required Intervention