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

Model Number 532598B

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

Patient Problem Vascular Dissection (3160)

Event Type  Injury  

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.

Event 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.No other information could be obtained.Additional information regarding event details, including, but not limited to patient information, clarification on the number of patients and lot number was requested; however, additional information could not be obtained.

• Brand Name: CATH MB 5F PIG 110CM 6SH
• Type of Device: 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: 14681212
• MDR Text Key: 293912651
• Report Number: 9616099-2022-05710
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032012034
• UDI-Public: 10705032012034
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 532598B
• Device Catalogue Number: 532598B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/13/2022
• 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