MAUDE Adverse Event Report: CORDIS CORPORATION SI BRITE TIP 7F 11CM STR; INTRODUCER, CATHETER

Model Number	401711M
Medical Device Problem Codes	Stretched (1601); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the mini guidewire of a 7f 11cm brite tip catheter sheath introducer (csi) unraveled while in patient.Fortunately, the wire was able to be retrieved before it broke off in the patient.There was no leftover material in the body.The issue was noted when they had difficulty advancing the wire.The procedure was completed normally after wire was removed.There was no reported patient injury.The patient has a history of paroxysmal a-fib.The device was kept in our storeroom that is kept at an acceptable temperature and humidity.There were no anomalies noted when removed from the package.Wire was removed from the packaging by the back end of the wire.The device was prepped per the instructions for use (ifu).Right femoral venous access for sheath placement during an electrophysiology (ep) study.The lesion was not calcified.There was little vessel tortuosity and vessel angulation.The device was not used for a chronic total occlusion (total occlusion >3 months).The device will not be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b5, g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: as reported, the mini guidewire of a 7f 11cm brite tip catheter sheath introducer (csi) unraveled while in patient.Fortunately, the wire was able to be retrieved before it broke off in the patient.There was no leftover material in the body.The issue was noted when they had difficulty advancing the wire.The procedure was completed normally after wire was removed.There was no reported patient injury.An image review showed an x-ray of a patient's right groin showing what appeared to be a wire located within the common femoral/external iliac artery.The patient has a history of paroxysmal a-fib.The device was kept in our storeroom that is kept at an acceptable temperature and humidity.There were no anomalies noted when removed from the package.The wire was removed from the packaging by the back end of the wire.The device was prepped per the instructions for use (ifu).Right femoral venous access was obtained for sheath placement during an electrophysiology (ep) study.The lesion was not calcified.There was little vessel tortuosity and vessel angulation.The device was not used for a chronic total occlusion (total occlusion >3 months).The device will not be returned for evaluation.The product was not returned for analysis.A product history record (phr) review of lot 18114077 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, the reported customer event ¿mini guidewire-unraveled/stretched-in patient¿ could not be confirmed.Procedural and/or 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, ¿holding the needle in place, insert the flexible end of the guidewire through the needle and into the vessel.If a j tip is used, slide the guidewire introducer over the j to straighten it for insertion.Gently advance the guidewire to the desired depth.¿ 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.
Event or Problem Description
As reported, the mini guidewire of a 7f 11cm brite tip catheter sheath introducer (csi) unraveled while in patient.Fortunately, the wire was able to be retrieved before it broke off in the patient.There was no leftover material in the body.The issue was noted when they had difficulty advancing the wire.The procedure was completed normally after wire was removed.There was no reported patient injury.An image review showed an x-ray of a patient's right groin showing what appeared to be a wire located within the common femoral artery/external iliac artery.The patient has a history of paroxysmal a-fib.The device was kept in our storeroom that is kept at an acceptable temperature and humidity.There were no anomalies noted when removed from the package.Wire was removed from the packaging by the back end of the wire.The device was prepped per the instructions for use (ifu).Right femoral venous access for sheath placement during an electrophysiology (ep) study.The lesion was not calcified.There was little vessel tortuosity and vessel angulation.The device was not used for a chronic total occlusion (total occlusion >3 months).The device will not be returned for evaluation.

• Brand Name: SI BRITE TIP 7F 11CM STR
• Common Device Name: INTRODUCER, CATHETER
• 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: 16117941
• Report Number: 9616099-2023-06207
• Device Sequence Number: 5753823
• Product Code: DYB
• UDI-Device Identifier: 10705032000307
• UDI-Public: (01)10705032000307(17)250430(10)18114077
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K984500
• 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,Followup
• Report Date (Section B): 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 401711M
• Device Catalogue Number: 401711M
• Device Lot Number: 18114077
• 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: 12/13/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 01/12/2023
• Date Device Manufactured: 06/01/2022
• 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
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 72 KG