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

Model Number	401711M
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, after a puncture was made, there was difficulty inserting a 7f 11cm straight brite tip catheter sheath introducer (csi) into the patient.After multiple attempts by the physician to insert the 7f brite tip csi, the distal portion of the csi became frayed.As a result, a 7f non-cordis csi was used in pace of the brite tip csi to continue the procedure.There was no vessel trauma caused to the patient as a result of the malfunction, and no other patient injuries were reported.It was reported that the gap between the csi and the dilator was causing the insertion difficulty.The right femoral artery was accessed for this procedure.There was mild calcification and mild tortuosity to the access vessel.However, there was no stenosis or stents placed within the access vessel.The device was stored and prepped per the instructions for use (ifu) and there was no difficulty prepping the device.There was no difficulty inserting the dilator into the brite tip csi, and no damage was observed to the csi prior to use.Saline was sued to wet the device prior to its attempted insertion.Additionally, there was no separation of the device observed.The device has been discarded and will not be returned.
Additional Manufacturer Narrative
Complaint conclusion: as reported, after a puncture was made, there was difficulty inserting a 7f 11cm straight brite tip catheter sheath introducer (csi) into the patient.After multiple attempts by the physician to insert the 7f brite tip csi, the distal portion of the csi became frayed.As a result, a 7f non-cordis csi was used in pace of the brite tip csi to continue the procedure.There was no vessel trauma caused to the patient because of the malfunction, and no other patient injuries were reported.It was reported that the gap between the csi and the dilator was causing the insertion difficulty.The right femoral artery was accessed for this procedure.There was mild calcification and mild tortuosity to the access vessel.However, there was no stenosis or stents placed within the access vessel.The device was stored and prepped per the instructions for use (ifu) and there was no difficulty prepping the device.There was no difficulty inserting the dilator into the brite tip csi, and no damage was observed to the csi prior to use.Saline was used to wet the device prior to its attempted insertion.Additionally, there was no separation of the device observed.The product was discarded and therefore, not available for analysis.A product history record (phr) review of lot 18095443 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 events, catheter sheath introducer-insertion difficulty, brite tip/distal tip-frayed/split/torn-in patient and vessel dilator-incompatibility/fit could not be confirmed.Handling factors and/or patient specific anatomical characteristics may have contributed to the reported events.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, ¿if increased resistance is felt upon insertion of the csi, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure, and withdraw the csi.¿ 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: 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: 15407145
• Report Number: 9616099-2022-05966
• Device Sequence Number: 15163445
• Product Code: DYB
• UDI-Device Identifier: 10705032000307
• UDI-Public: (01)10705032000307(17)250228(10)18095443
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2022

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: 02/28/2025
• Device Model Number: 401711M
• Device Catalogue Number: 401711M
• Device Lot Number: 18095443
• 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: 08/18/2022
• Initial Report FDA Received Date: 09/12/2022
• Date Device Manufactured: 03/17/2022
• 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: 7F TERUMO CSI
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 76 KG