MAUDE Adverse Event Report: CORDIS CORPORATION CATH MB 5F PIG 110CM 6SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	532598B
Health Effect - Clinical Code	Vascular Dissection (3160)
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, a doctor called the distributor informing that the 5f 6 side holes (sh)110cm super torque marker band (mb) pigtail catheter (cath mb 5f pig 110cm 6sh) resected the aorta during the use.This issue happened two times in less than 24 hours (two different patients with two different products).No other information could be obtained.Additional event details were not provided.
Additional Manufacturer Narrative
As reported, a doctor called the distributor informing that the 5f 6 side holes (sh)110cm super torque marker band (mb) pigtail catheter (cath mb 5f pig 110cm 6sh) resected the aorta during use.This issue happened twice in less than 24 hours (two different patients with two different products).The products were not returned for analysis and a product history record (phr) review could not be performed because the lot number for these products are unknown.Without the return of the device or images for analysis, the reported customer event ¿aortic dissection¿ could not be confirmed.Vessel characteristics or user technique may have contributed to the reported event.Dissection is a known and extensively documented potential complication of this type of procedure and is listed in the instructions for use (ifu) as such.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, ¿complications may occur at any time during or after the procedure.Possible complications include, but are not limited to, the following: air embolism, hematoma at the puncture site, infection, thrombosis, hemorrhage, dissection, perforation, or other damage of the vessel wall.Prior to using the device, inspect for bends, kinks, or other damage.¿ based on the information available, 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: CATH MB 5F PIG 110CM 6SH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 14682092
• Report Number: 9616099-2022-05713
• Device Sequence Number: 14723607
• Product Code: DQO
• UDI-Device Identifier: 10705032012034
• UDI-Public: 10705032012034
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K915836
• 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
• Report Date (Section B): 06/13/2022

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 Model Number: 532598B
• Device Catalogue Number: 532598B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/13/2022
• 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
• Patient Sex: Unknown