MAUDE Adverse Event Report: CORDIS CORPORATION 6F10CM PW22 RADIAL; INTRODUCER, CATHETER

Model Number	506610P22G
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Vasoconstriction (2126); Discomfort (2330); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, when using a 6f rain sheath in a percutaneous coronary intervention (pci), the physician observed the patient had severe radial spasm during the intervention when the guide catheter was used which made the procedure difficult.After the procedure, the physician assistant was unable to withdraw the sheath due to the spasm even after administering nitroglycerin.The patient was then given sedation to lessen discomfort when the sheath was pulled out.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, the patient had a severe radial spasm while using a 6f rain sheath in a percutaneous coronary intervention (pci), which made the procedure difficult.The physician observed the radial spasm while using a guide catheter.After the procedure, nitroglycerin was administered however, the physician assistant was unable to withdraw the sheath.The patient was then given sedation to lessen discomfort and the sheath was pulled out.The lesion was not calcified, there was eighty percent stenosis and vessel tortuosity was moderate.The device was not used for a chronic total occlusion.The sheath size was appropriate for the vessel.The access site was not highly calcified.No anomalies were noted when the product was removed from the package.The product was stored, handled, inspected and prepped according to the instructions for use (ifu).The access needle was flushed prior to use, and the air was removed from the catheter sheath introducer (csi) through the side port extension by inverting and flushing with heparinized saline or suitable isotonic solution.The radial artery spasm occurred during the end of the intervention.The sheath was in place for thirty minutes and was not used for any infusions.The device was not caught in the vessel during removal.One non-sterile unit of 6f10cm pw22 radial was received for analysis.Only the cannula, vessel dilator and a mini guidewire were returned for analysis.During visual inspection, the cannula was observed compressed and kinked.The damage extended from 4cm to the distal tip to 10 cm from the distal tip.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.A product history record (phr) review of lot 18071334 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The failure reported by the customer as " catheter sheath introducer (csi) - withdrawal difficulty¿ could not be properly evaluated and confirmed due the nature of the complaint.The reported radial artery spasm is the likely cause of the event.Arterial spasm is a known potential adverse event associated with any interventional procedure where devices are introduced into the vasculature.Local vasospasm can be caused by the device manipulations inherent in any procedure causing endothelial irritation.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿hold the sheath in place when inserting, positioning, or removing the catheter.Possible complications include, but are not limited to: abrupt vessel closure, additional intervention, allergic reaction (device, contrast medium and medications), air embolism, infection, intimal tear, hematoma at puncture, hemorrhage, inflammation / infection / sepsis, ischemia, perforation of vessel wall, thrombus formation, peripheral nerve injury, pain, vascular complications (e.G.Intimal tear, dissection, pseudo aneurysm, perforation, rupture, spasm, occlusion¿.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: 6F10CM PW22 RADIAL
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 13758651
• Report Number: 9616099-2022-05450
• Device Sequence Number: 11361572
• Product Code: DYB
• UDI-Device Identifier: 10705032082174
• UDI-Public: 10705032082174
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K181592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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: 10/31/2024
• Device Model Number: 506610P22G
• Device Catalogue Number: 506610P22G
• Device Lot Number: 18071334
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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: GUIDE CATHETER.
• Patient Sex: Male