MAUDE Adverse Event Report: CORDIS CORPORATION 6F10CM NW RADIAL; RADIOIMMUNOASSAY, GENTAMICIN (125-I), SECOND ANTIBODY SEP.

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vasoconstriction (2126)

Event Date 02/16/2022

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

During a left heart cath procedure, a 6f rain sheath device was not very lubricious when entering the radial artery causing an arterial spasm upon entry.They gave a cocktail to assist.The procedure was successfully completed by using a non-cordis sheath.

Manufacturer Narrative

During a left heart cath procedure, a 6f rain sheath device was not very lubricious when entering the radial artery causing an arterial spasm upon entry.They gave a cocktail to assist.The procedure was successfully completed by using a non-cordis sheath.The product was not returned for analysis.A product history record (phr) review of lot 18071333 revealed no anomalies or non-conformance's during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer event ¿catheter sheath introducer-insertion difficulty¿ could not be confirmed.Procedural/handling factors such as failure to activate the hydrophilic coating by soaking the device in an isotonic solution may have contributed to the reported 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, ¿soak the csi in sterile heparinized saline or similar isotonic solution to activate the hydrophilic coating.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 NW RADIAL
• Type of Device: RADIOIMMUNOASSAY, GENTAMICIN (125-I), SECOND ANTIBODY SEP.
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13841201
• MDR Text Key: 287578023
• Report Number: 9616099-2022-05471
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 20705032082165
• UDI-Public: (01)20705032082165(17)241031(10)18071333
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 506610N
• Device Lot Number: 18071333
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NON-CORDIS SHEATH.