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

Catalog Number	506510N
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 5f 10 cm trans radial rain sheath accordioned as it was attempted to be inserted in a left pedal artery with guided ultrasound (us).There was difficulty inserting and withdrawing due to the accordioned condition of device.When attempting to remove the sheath over the wire.The csi wire became entrapped during the procedure and abnormal force was required when withdrawing the device.The wire and sheath were removed.The distal tip of the wire broke off the rest of the wire.The wire was successfully retrieved and removed by the physician.There were no reports of patient injury.The device was used in an interventional endovascular percutaneous transluminal angioplasty (pta).The device was prepped, flushed, and wiped with heparinized saline prior to insertion to activate the hydrophilic coating.The sheaths are stored in the product box in a temp/humidity-controlled procedure room.The sheath was inspected prior to use, with no defects noted.Severe calcification was noted by the physician via ultrasound.The length of stay was not increased due to the product malfunction.Another 5f rain sheath was used for the procedure.The vessel dilator was snapped into place at the hub.The device was prepped per the instructions for use (ifu).The csi had been wiped down with a wet gauze.There were no anatomical anomalies with the patient.The device will be returned for evaluation.
Additional Manufacturer Narrative
The product history review is expected but has not been completed.The device is available for analysis, but the engineering report is not yet available.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: d2, d3, g1, g3, g6, h1, h2, h3, h6, and h10 -a review of the manufacturing documentation associated with lot 18120489 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.
Additional Manufacturer Narrative
This fda report was generated due to phr completion, however phr was reopened for revisions and is still pending.The device is available for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
An attempt was made to insert a 5f rain sheath (506510n lot 18120489) into a left pedal artery.The sheath accordioned.When attempting to remove the sheath over the wire, there was difficulty.Therefore, the wire and sheath were removed.The distal tip of the wire broke off the rest of the wire.The wire was successfully retrieved and removed by the physician.The procedure was an interventional endovascular pta.Access was through the left pedal artery via ultrasound guided access.The device was prepped, flushed, and wiped with heparinized saline prior to insertion to activate the hydrophilic coating.The sheaths are stored in the product box in a temp/humidity-controlled procedure room.The sheath was inspected prior to use, with no defects noted.Severe calcification was noted by the physician via ultrasound.There was no patient harm noted, and their length of stay was not increased due to the product malfunction.Another 5f rain sheath was used for the procedure.One non-sterile unit of a ¿5f10cm nw radial¿ was received for analysis.During visual inspection, the tip of the cannula was found in an accordioned condition.Additionally, an unknown non-cordis mini guidewire was returned.The mini guidewire has a different color and is stiffer than the cordis mini guidewire because the body is solid, not coiled like the cordis mini guidewire.Inner diameter (id) and outer diameter (od) measurements were taken and found within specification.During functional analysis, a lab sample guidewire was inserted into the vessel dilator without any difficulty.Additionally, the vessel dilator was inserted into the cannula and no anomalies were observed.A product history record (phr) review of lot 18120489 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)-withdrawal difficulty¿ and ¿catheter sheath introducer (csi)- insertion difficulty¿ " cannot be confirmed due to the nature of the event.The complaint reported by the customer as catheter sheath introducer (csi)- accordioned was confirmed since this condition was found at the tip of the cannula.The complaint reported by the customer as ¿mini guidewire~ fractured-separated¿ was not confirmed since a non-cordis guidewire was returned.Patient specific anatomical features 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, ¿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.Thread the csi with vessel dilator over the guidewire, grasping the sheath close to the skin to prevent buckling.Advance the assembly through the tissue and into the vessel.¿ based on the available information, 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; 14021 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17026416
• Report Number: 9616099-2023-06509
• Device Sequence Number: 7031446
• Product Code: DYB
• UDI-Device Identifier: 10705032082150
• UDI-Public: (01)10705032082150(17)250531(10)18120489
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: 506510N
• Device Lot Number: 18120489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• 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: 05/05/2023
• Supplement Date Received by Manufacturer: 05/31/2023; 07/04/2023; 03/02/2024
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/26/2023; 07/28/2023; 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2022
• 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: 83 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Race: White