MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO 244 S DE RL DE CV CATH TEMPO AQUA 5FVER135O100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

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

Patient Problem Vasoconstriction (2126)

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device history review could not be performed since complaint lot is unknown.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

When a 5f 100cm vertebral tempo agua diagnostic catheter was withdrawn in an interventional procedure, the patient's vagus reflex was too strong, heart rate slowed down, and the patient lost consciousness.The patient has been discharged from the hospital without any adverse consequences after reasonable treatment.The product that caused the adverse event has been discarded by the hospital and cannot be returned, the lot number is unknown.Symptoms such as slow heart rate and transient loss of consciousness after stimulation of the vagus reflex mentioned in the reported information are transient, mainly due to the long time of pressing the puncture port and excessive pressure, which is not directly related to the tempo catheter.The device will not be returned for analysis.

Manufacturer Narrative

Additional b5 narrative: the lot number is not available.The low blood pressure was not treated.The patient regained consciousness and the blood pressure returned to normal before discharge.There were no anomalies noted on the tempo catheter before use.The product was inspected and prepped according to the instructions for use.Additional patient and procedural details were requested but were unknown.The product will not be returned for analysis.As reported, when a 5f 100cm vertebral tempo agua diagnostic catheter was withdrawn in an interventional procedure, the patient's vagus reflex was too strong, heart rate slowed down, and the patient lost consciousness.The patient has been discharged from the hospital without any adverse consequences after reasonable treatment.The product that caused the adverse event has been discarded by the hospital.The lot number is unknown.Per the medical staff, "symptoms such as slow heart rate and transient loss of consciousness after stimulation of the vagus reflex mentioned in the reported information are transient, mainly due to the longtime of pressing the puncture port and excessive pressure, which is not directly related to the tempo catheter." the low blood pressure was not treated.The patient regained consciousness and the blood pressure returned to normal before discharge.There were no anomalies noted on the tempo catheter before use.The product was inspected and prepped according to the instructions for use.The product was not returned for analysis as it was discarded.The lot number was not provided therefore, a product history record (phr) review could not be performed.Based on the limited information provided, it is not possible to draw a clinical conclusion between the device and the reported event.Without a lot number, return of the device or procedural images for analysis, the reported customer event ¿presyncope¿ could not be confirmed, and the exact root cause could not be determined.Vagal reactions may occur while applying pressure to the groin during percutaneous procedures in which arterial or venous access is obtained.Pressure on a large artery can stimulate the vagus nerve, stimulating a parasympathetic response, i.E., bradycardia, hypotension, presyncope, syncope, heart block, asystole, etc.Causing slowing of the heart rate and a drop in blood pressure.Anxiety, pain, and discomfort at the puncture site may also result in a vagal reaction.Early signs include pallor, nausea and/or yawning, which often present with a slowing of the heart rate before a drop in blood pressure.This is a known potential complication with any invasive procedure during which pressure is applied to the groin area.According to the instructions for use (ifu), ¿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 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 TEMPO AQUA 5FVER135O100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CARDINAL HEALTH MEXICO 244 S DE RL DE CV; santiago troncoso 808; juarez 32574 ; MX 32574
• Manufacturer (Section G): CARDINAL HEALTH MEXICO 244 S DE RL DE CV; santiago troncoso 808; juarez 32574 ; MX 32574
• Manufacturer Contact: karla castro ; 14201 nw 60th ave,; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12953185
• MDR Text Key: 282325327
• Report Number: 9616099-2021-05122
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K000579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 452514H0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: UNK.
• Patient Outcome(s): Life Threatening; Hospitalization