MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON V5MS; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number 08264577

Device Problem Difficult to Insert (1316)

Patient Problems Chest Pain (1776); Dysphagia/ Odynophagia (1815); Hematoma (1884); Necrosis (1971); Laceration(s) of Esophagus (2398)

Event Date 09/18/2017

Event Type  Injury  

Event Description

Loss of esophagus; user facility was the (b)(6) hospital.Patient underwent a transesophageal echocardiogram (tee) as part of a cardiac ablation procedure.Medical records indicate the probe (acuson v5ms; model number 08264577; last four digits of the serial number are (b)(4); manufacturer: siemens), insertion was difficult and the physician in charge of the case was asked to assist with probe insertion at the tee tech's request.Tee was completed and ablation procedure began.Blood was noted coming from the patients mouth towards the end of the ablation procedure.Medical records indicate patient was coughing up blood and complaining of chest and back pain and dysphagia while in the pacu.Due to continued symptoms, an esophagram was ordered post-operative day 1, and was found to show esophageal injury.A ct scan taken that evening should extensive esophageal damage, a likely intramural esophageal hematoma.Patient was transferred to a different facility post-op day 2, where he underwent emergency surgery to assess and possibly repair the damage.That surgeon reported a 21-cm long injury in the esophagus and necrotic and ischemic esophageal tissue and performed a transhiatal esophagectomy to remove most of the esophagus.The patient's stomach was rearranged and attached to what was left of the esophagus to restore some fraction of digestive tract function.Fda safety report id # (b)(4).

• Brand Name: ACUSON V5MS
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.
• MDR Report Key: 10553127
• MDR Text Key: 207717931
• Report Number: MW5096733
• Device Sequence Number: 1
• Product Code: ITX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08264577
• Device Catalogue Number: 7472629
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 56 YR
• Patient Weight: 100