MAUDE Adverse Event Report: CORDIS CORPORATION 6F 10CM SW RADIAL; INTRODUCER, CATHETER

Model Number 506610S

Device Problem Difficult to Remove (1528)

Patient Problem Vasoconstriction (2126)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

A 6f 10cm sw transradial rain sheath would not come out from the patient¿s body and a radial artery spasm was noted while the radial sheath was in patient.The spasm was treated with 10 mg verapamil 200 mics of nitro.The sheath was in place for 45 to 60 minutes.It was eventually removed using standard protocol.They let the patient relax for about an hour after the procedure was completed.It took 10 to 20 minutes to get access using the needle supplied with the device.The access site was not changed but they paused several times to allow the artery to relax because it was spasming.The procedure being performed was a percutaneous coronary intervention (pci).The patient had a small radial artery.The device was properly stored and opened in a sterile field.The sheath size was appropriate for the vessel.The access site was not highly calcified.The product appeared normal when taken from its packaging.It also prepped normally.The access was needle flushed prior to use.Prior to use, the air was removed from the csi through the side port extensions by inverting and flushing with heparinized saline or suitable isotonic solution.The device was caught in the vessel during removal.It will not be returned for evaluation.Additional patient information was requested but was not available.

Manufacturer Narrative

A 6f 10cm sw transradial rain sheath would not come out from the patient¿s body and a radial artery spasm was noted while the radial sheath was in patient.The spasm was treated with 10 mg verapamil 200 mics of nitro.The sheath was in place for 45 to 60 minutes.It was eventually removed using standard protocol.They let the patient relax for about an hour after the procedure was completed.It took 10 to 20 minutes to get access using the needle supplied with the device.The access site was not changed but they paused several times to allow the artery to relax because it was spasming.The procedure being performed was a percutaneous coronary intervention (pci).The patient had a small radial artery.The device was properly stored and opened in a sterile field.The sheath size was appropriate for the vessel.The access site was not highly calcified.The product appeared normal when taken from its packaging.It was prepped normally.The access was needle flushed prior to use.Prior to use, the air was removed from the csi through the side port extensions by inverting and flushing with heparinized saline or suitable isotonic solution.The device was caught in the vessel during removal.The product was not returned for analysis.A product history record (phr) review of lot 17944854 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿withdrawal difficulty¿ and ¿vasospasm¿ could not be confirmed as the device was not returned for analysis.The exact cause of the reported events could not be conclusively determined.Patient or procedural factors may have contributed to the reported events.Vessel spasm is a known potential adverse event associated with any interventional procedure where devices are introduced into the vasculature and is listed in the ifu (instructions for use) as such.S cautioned in the instructions for use (ifu), which is not intended as a mitigation, ¿if resistance is felt upon insertion or withdrawal, investigate the cause before continuing.¿ additionally, the ifu states, ¿once all catheters and wires are removed, remove the sheath when clinically indicated by placing compression on the vessel above the puncture site, and slowly withdraw the csi.Discard the sheath appropriately.Important: upon removing any intravascular device, aspirate via the side port extension to collect any fibrin that may have been deposited within or at the tip of the device.Neither the phr review nor the information available suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.

• Brand Name: 6F 10CM SW RADIAL
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave,; miami lakes FL 33014
• MDR Report Key: 10677616
• MDR Text Key: 211296278
• Report Number: 9616099-2020-03980
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K181592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 506610S
• Device Catalogue Number: 506610S
• Device Lot Number: 17944854
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 10/19/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention