MAUDE Adverse Event Report: CORDIS CORPORATION 6F10CM SW RADIAL; INTRODUCER, CATHETER

Model Number N/A

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17992784 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 Description

Upon insertion of a 6f 10cm sw transradial rain sheath, there was a large amount of hydrophilic coating that seemed to sheer off.Coating was present on both sides of the sheath just outside of the tissue tract at the puncture site.The physician wiped the excess coating away and proceeded with case.When removing the rain sheath there was a little resistance, the scrub tech rotated the sheath from side to side in an effort to remove.Following the case, the scrub tech placed a non-cordis band and hemostasis was achieved.There was no reported patient injury.The procedure was a diagnostic coronary procedure.There was no vessel tortuosity, no calcification, and no angulation of the radial artery access site.There were no anomalies noted when removed from the package.There were no anomalies noted during prep other than the reported complaint.The device was stored and prepped as per the instructions for use (ifu).The user and tech were trained with the device.The sheath was not soaked in a saline bath; it was dipped in the saline bath and handed off to the physician.Rain sheath was prepped by dipping in a saline bath on back table.Scrub tech immediately passed the rain sheath off to the physician.The physician advanced the sheath over the wire and no resistance was evident.Other procedural details were requested but are unknown, unavailable, or not applicable.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, and h10.This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available due to need for additional testing/review of additional information submitted.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

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: upon insertion of a 6f 10cm sw transradial rain sheath, there was a large amount of hydrophilic coating that seemed to sheer off.Coating was present on both sides of the sheath just outside of the tissue tract at the puncture site.The physician wiped the excess coating away and proceeded with the case.When removing the rain sheath there was some resistance and the scrub tech rotated the sheath from side to side in an effort to remove it.Subsequently, the scrub tech placed a non-cordis band and hemostasis was achieved.The procedure was a diagnostic coronary procedure.There was no vessel tortuosity, no calcification and no angulation of the radial artery.There were no anomalies noted when removed from the package or during prep.The device was stored and prepped as per the instructions for use (ifu).The user and the tech were trained with the device.The sheath was not soaked in a saline bath.It was dipped in the saline bath on a back table and immediately handed off to the physician.The physician advanced the sheath over the wire and no resistance was evident.Other procedural details were requested but are unknown, unavailable, or not applicable.There was no reported patient injury.The device was returned for analysis.Per visual analysis, one non-sterile unit of a catheter sheath introducer (6f10cm sw radial) was received.During the visual inspection, a kink/bent condition was found at the canula at 10 com from the distal tip.In addition, it was noted a compressed/crushed area at the canula located at 7 cm from the distal tip.Dimensional analysis results were found within specification.A red congo functional test was performed.The sample was tested with red congo solution.Based on the visual characteristics, it can be concluded that the devices presented evidence that they were coated during the manufacturing process.A product history record (phr) review of lot 17992784 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter sheath introducer (csi)-withdrawal difficulty¿ could not be confirmed since it was not possible to perform a proper evaluation due to the returned condition of the device.The reported ¿coating-sheaths-separated¿ was confirmed by analysis since different saturation grades of the stain with red congo was observed.However, it can be concluded that the devices presented evidence that they were coated during the manufacturing process.Different saturation grades of the samples can be attributed to multiple factors during procedure, post-procedure and as part of the decontamination process.According to the ifu, which is not intended as a mitigation of risk, ¿carefully remove csi from package using sterile technique.Caution: to prevent damage while removing sheath from package, gently pull up the side port (at the sheath hub) to remove from the package.Inspect the system contents for any signs of damage; do not use if any damage is present.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.¿ additionally, the ifu cautions users ¿if resistance is felt upon insertion or withdrawal, investigate the cause before continuing.¿ the product analysis available suggests a manufacturing related cause for the reported event; therefore, a risk assessment has been initiated to further investigate the cause.

• Brand Name: 6F10CM SW RADIAL
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11919010
• MDR Text Key: 253788746
• Report Number: 9616099-2021-04590
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 506610S
• Device Lot Number: 17992784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Date Manufacturer Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TR BAND; TR BAND