MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO CATH TEMPO 5F VER 135 DEGREE 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

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

Patient Problems Obstruction/Occlusion (2422); Vascular Dissection (3160)

Event Date 06/06/2021

Event Type  Injury  

Manufacturer Narrative

An anonymous complaint was posted to the (b)(6) stating, a 5f vertebral 135-degree 100cm tempo catheter dissected three selectively probed cervical arteries and two arteries were occluded.The device was intended to be used for cerebral arteriography to investigate cerebral hemorrhage.Additional information was unable to be obtained.The product was not returned for analysis.A product history record (phr) review of lot 17981425 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Based on the limited information provided, it is not possible to draw a clinical conclusion between the device and the reported event.Without the return of the device or procedural images for analysis, the reported customer event ¿artery dissection¿ and ¿arterial occlusion¿ could not be confirmed, and the exact root cause could not be determined.Dissection is a well-known and extensively documented potential complication of a percutaneous intervention.The physical manipulation inherent in this type of procedure can disrupt the vessel plaque and intima.Vessel characteristics such as calcified lesions or tortuous vessels and/or procedural factors can contribute to a dissection occurring.Arterial occlusion is a potential sequelae of dissection.According to the instructions for use (ifu), although not intended as a mitigation of risk, to prevent damage to the catheter tip during removal from the package, grasp the hub and gently withdraw the catheter.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.Complications may occur at any time during or after the procedure.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 Description

As reported, a 5f vertebral 135-degree 100cm tempo catheter dissected three selectively probed cervical arteries and two arteries were occluded.The device was intended to be used for cerebral arteriography to investigate cerebral hemorrhage.The complaint was posted anonymously at anvisa¿s website so it is impossible to obtain more information.The device will not be returned for evaluation.

• Brand Name: CATH TEMPO 5F VER 135 DEGREE 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 12210363
• MDR Text Key: 262880757
• Report Number: 9616099-2021-04724
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032008461
• UDI-Public: 20705032008461
• Combination Product (y/n): N
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 451514H0
• Device Lot Number: 17981425
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2020
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention