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
Additional Manufacturer Narrative
This case is related to case-(b)(4) report id 9616099-2022-05713.
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.

• 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: 14682228
• Report Number: 9616099-2022-05714
• Device Sequence Number: 5084383
• 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: Other
• 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