MAUDE Adverse Event Report: CORDIS CORPORATION RAIN SHEATH TRANSRADIAL; INTRODUCER, CATHETER

Catalog Number	506510N
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the guidewire of a 5f 10cm rain trans-radial catheter sheath introducer (csi) was split into two parts during preparation of the device.As a result, the same 5f 10cm rain csi was used with an unknown guidewire to continue the procedure.There was no reported injury to the patient.There were no difficulties during the insertion or withdrawal of the csi.The device will be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18143902 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report 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.
Event or Problem Description
As reported, the guidewire of a 5f 10cm rain trans-radial catheter sheath introducer (csi) was split into two parts during preparation of the device.As a result, the same 5f 10cm rain csi was used with an unknown guidewire to continue the procedure.There was no reported injury to the patient.There were no difficulties during the insertion or withdrawal of the csi.The device has now been returned.
Event or Problem Description
As reported, the guidewire of a 5f 10cm rain trans-radial catheter sheath introducer (csi) was split into two parts during preparation of the device.As a result, the same 5f 10cm rain csi was used with an unknown guidewire to continue the procedure.There was no reported injury to the patient.There were no difficulties during the insertion or withdrawal of the csi.The device was not returned as expected.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, b5, d4, d9, g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: as reported, the guidewire of a 5f 10cm rain trans-radial catheter sheath introducer (csi) was split into two parts during preparation of the device.As a result, the same 5f 10cm rain csi was used with an unknown guidewire to continue the procedure.There was no reported injury to the patient.There were no difficulties during the insertion or withdrawal of the csi.The product was not returned for analysis.A product history record (phr) review of lot 18143902 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 ¿mini guidewire-fractured/separated¿ could not be confirmed and the exact cause of separation cannot be determined.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, ¿do not use if package is open or damaged., remove the product from the packaging tray with care to avoid damage to the sheath.Do not withdraw the guidewire back though the metal cannula of the needle after it has been inserted as it may damage the guidewire.¿ 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.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: as reported, the guidewire of a 5f 10cm rain trans-radial catheter sheath introducer (csi) was split into two parts during preparation of the device.As a result, the same 5f 10cm rain csi was used with an unknown guidewire to continue the procedure.There was no reported injury to the patient.There were no difficulties during the insertion or withdrawal of the csi.A non-sterile mini guidewire belonging to a ¿5f10cm nw radial¿ was received for analysis.During visual inspection, an unraveled condition was noted to the radiopaque distal coil wire.No other damages or anomalies were observed.The unit was inspected using a vision system to obtain a magnified image and presented evidence of an unraveled condition to the coil wire.The proximal and distal end remain attached to the core wire.The unraveling of the coil wire resulted in the exposure of the core wire.The coil wire does not present with a separated condition.The core wire was fractured/separated into two pieces.Both sections were returned for analysis.Sem analysis presented evidence of striation and elongation patterns.A product history record (phr) review of lot 18143902 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿mini guidewire ~ fractured - separated¿ was confirmed.A separation was observed on the distal end of the core wire.The striation and elongation patterns identified at the separated sections of the core wire are commonly associated with plastic deformation when materials are exposed to excessive mechanical stress.This happens when the resistance properties are overloaded, which results in fatigue failure.Therefore, it is assumed the wire was induced to a tensile force that exceeded its material yield strength prior to the separation.The exact cause of these findings cannot be conclusively determined during the analysis however, handling factors while preparing the device may have led to the separation.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, ¿carefully remove csi from package using sterile technique.Inspect the system contents for any signs of damage; do not use if any damage is present.¿ 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: RAIN SHEATH TRANSRADIAL
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17463278
• Report Number: 9616099-2023-06572
• Device Sequence Number: 20621285
• Product Code: DYB
• UDI-Device Identifier: 10705032082150
• UDI-Public: (01)10705032082150(17)250831(10)18143902
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/04/2024

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
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: 506510N
• Device Lot Number: 18143902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 08/04/2023; 08/16/2023; 12/27/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 08/10/2023; 09/08/2023; 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2022
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White