MAUDE Adverse Event Report: CORDIS CORPORATION BRITE TIP RADIANZ 110CM; INTRODUCER, CATHETER

Model Number	687280110
Medical Device Problem Codes	Stretched (1601); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18074757 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the distal 30cm portion of a 110cm brite tip radianz catheter sheath introducer appeared to be "stretch/ribbon." it is suspected that it ribboned because the user removed the sheath without having a wire or dilator in.Following completion of the intervention, the physician was able to remove the brite tip radianz over an unknown guidewire.The right femoral artery was closed with mynx grip.There was no reported patient injury.No damage to the vessel or patient.No complications following the procedure.The brite tip was used for a left lower extremity angiogram, through the right common femoral artery.Throughout case the physician used an unknown drug coated balloon (dcb) and shockwave.An image review was completed for three images received, and they show what appears to be stretching of a catheter.The device will be returned for evaluation.
Additional Manufacturer Narrative
This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: as reported, the distal 30cm portion of a 110cm brite tip radianz catheter sheath introducer appeared to "stretch/ribbon." it is suspected that it ribboned because the user removed the sheath without having a wire or dilator in.Following completion of the intervention, the physician was able to remove the brite tip radianz over an unknown guidewire.The right femoral artery was closed with mynx grip.There was no reported patient injury.No damage to the vessel or patient.No complications following the procedure.The brite tip was used for a left lower extremity angiogram, through the right common femoral artery.Throughout case the physician used an unknown drug coated balloon (dcb) and shockwave.Three pictures were submitted for analysis.Picture one shows a cordis brite tip radianz that is stretched near distal area of the guiding sheath.A stretched/compressed condition near the distal end of the device is noted in pictures 2 and 3 with blood residue observed on the unit.One non-sterile unit of a brite tip radianz 110cm was received for analysis.During visual inspection, the unit was found compressed/crushed on the cannula extending 1.8 to 49.5 cm from the distal tip.Kinked/bent conditions were also noted and located approximately 50.6, 74.6 and 85.2 cm from the distal tip.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Additionally, the usable length was measured and was also found within specification.A product history record (phr) review of lot 18074757 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event by the customer ¿cannula ¿ unraveled/stretched - in patient¿ was not confirmed.The device was not received unraveled or stretched and the usable length was found within specification.Compressed/crushed and kink/bents conditions were found on the cannula of the device.Dimensional analysis was performed to verify the correct catheter id and od, the results were found within specification.The exact cause of these conditions cannot be conclusively determined however, vessel characteristics and/or handling factors might 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, ¿once the vessel dilator is removed, manipulate the catheter guiding sheath slowly and carefully to minimize the chance of kinking.Once interventional / diagnostic device is removed, load the guidewire into the catheter guiding sheath and advance until approximately 5 cm of the guidewire exit the distal tip of the sheath.Carefully withdraw the catheter guiding sheath and guidewire from the vessel.¿ 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: BRITE TIP RADIANZ 110CM
• 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: 15276227
• Report Number: 9616099-2022-05916
• Device Sequence Number: 6478950
• Product Code: DYB
• UDI-Device Identifier: 20705032081228
• UDI-Public: (01)20705032081228(17)231130(10)18074757
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• 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,Followup
• Report Date (Section B): 10/06/2022

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: 11/30/2023
• Device Model Number: 687280110
• Device Catalogue Number: 687280110
• Device Lot Number: 18074757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Supplement Date Received by Manufacturer: 09/05/2022; 10/03/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 09/30/2022; 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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: MYNX GRIP; SHOCKWAVE; UNKNOWN DRUG COATED BALLOON (DCB); UNKNOWN GUIDEWIRE
• Patient Sex: Male