MAUDE Adverse Event Report: CORDIS US. CORP RAIN SHEATH TRANSRADIAL; DEVICE, HEMOSTASIS, VASCULAR

Model Number	N/A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18190215 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, a 6f 10cm rain sheath radial catheter sheath introducer (csi) could not be introduced into the radial artery but "scratched" off.The coating of the sheath pulled off and pushed up.The procedure was completed using another non cordis csi.There was no reported patient injury.The csi was soaked; it was not wiped down with wet gauze.The patient did not have any unusually tough skin, scar tissue, or contractures of the joint.The procedure was completed using another non cordis csi.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, a 6f 10cm rain sheath radial catheter sheath introducer (csi) could not be introduced into the radial artery but "scratched" off.The coating of the sheath pulled off and pushed up.The procedure was completed using another non-cordis csi.There was no reported patient injury.The csi was soaked; it was not wiped down with wet gauze.The patient did not have any unusually tough skin, scar tissue, or contractures of the joint.The procedure was completed using another non-cordis csi.A non- sterile csi ¿6f,10cm sw radial" was received for evaluation.The returned components were the vessel dilator and the csi.The vessel dilator was received inserted inside the cannula of the csi.The unit was visually inspected and an accordioned condition extending 4 cm from the distal tip was noted.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Functional analysis was performed by flushing the vessel dilator and csi.The water flowed through the distal tip as expected.Neither resistance to the water flow nor loose material was observed during the procedure.One lab sample mini guide wire was inserted/withdrawn in the vessel dilator.No anomalies were observed.The lab vessel dilator with the lab sample mini guidewire was inserted as a single unit and withdrawn through the csi by the cap.No anomalies were observed.However, light resistance was felt in the accordioned zone.The unit was inspected with a vision system confirming the accordioned condition.A product history record (phr) review of lot 18190215 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿catheter sheath introducer (csi)~insertion difficulty¿ and ¿coating~delaminated¿ were not confirmed.The returned unit does not present with a delaminated condition and insertion difficulty cannot be determined in a laboratory setting.However, an accordioned condition was observed on the returned device.The exact cause of this condition could not be conclusively determined during the analysis.Procedural factors or patient specific anatomical features may have contributed to the reported insertion difficulty and subsequently led to the accordioned condition.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 resistance is felt upon insertion or withdrawal, investigate the cause before continuing.Soak the csi in sterile heparinized saline or similar isotonic solution to activate the hydrophilic coating.If using a hydrophilic access wire, soak the wire as well to activate the coating.¿ 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: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CORDIS US. CORP; 14021 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara 95054 ; 7863138372
• MDR Report Key: 17719722
• Report Number: 9616099-2023-06594
• Device Sequence Number: 20438207
• Product Code: MGB
• UDI-Device Identifier: 10705032078948
• UDI-Public: (01)10705032078948(17)260228(10)18190215
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023
• 2 Devices were Involved in the Event: 1 2

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: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: 506610S
• Device Lot Number: 18190215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2023
• 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: GLIDESHEATH SLENDER CSI
• Patient Age: 44 YR
• Patient Sex: Unknown