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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
His device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
A physician indicated that post procedure there was bleeding from the access site of the 6f 10cm transradial rain sheath.A radial compression band was applied and when they checked on the patient there was blood pooling.They reattached the band but again had bleeding.Doctor stated the only factor he could think of was that he is training with the new rain sheath (this was the first one he tried).The device was stored as per the labeling and was opened in a sterile field.It will be returned for analysis.
Additional Manufacturer Narrative
A physician indicated that post procedure there was bleeding from the access site of the 6f 10cm transradial rain sheath.A radial compression band was applied and when they checked on the patient there was blood pooling.They reattached the band but again had bleeding.Doctor stated the only factor he could think of was that he is training with the new rain sheath (this was the first one he tried).The device was stored as per the labeling and was opened in a sterile field.The product was not returned for analysis.A product history record (phr) review of lot 18079487 revealed no anomalies or non-conformances 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 ¿vascular access site bleeding¿ could not be confirmed as the result of a manufacturing related defect.Bleeding is a known potential adverse event associated with accessing an artery for diagnostic and interventional procedures.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, ¿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).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.¿ 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.
Event or Problem Description
A physician indicated that post procedure there was bleeding from the access site of the 6f 10cm transradial rain sheath.A radial compression band was applied and when they checked on the patient there was blood pooling.They reattached the band but again had bleeding.Doctor stated the only factor he could think of was that he is training with the new rain sheath (this was the first one he tried).The device was stored as per the labeling and was opened in a sterile field.The device will not be returned for analysis.

• Brand Name: 6F10CM SW RADIAL RAIN SHEATH
• Common Device Name: INTRODUCER, CATHETER
• 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 ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14337836
• Report Number: 9616099-2022-05614
• Device Sequence Number: 20154680
• Product Code: DYB
• UDI-Device Identifier: 10705032078948
• UDI-Public: (01)10705032078948(17)241231(10)1807948
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K181592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 506610S
• Device Lot Number: 18079487
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 05/14/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Patient Sex: Unknown