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

Model Number V5MS TRANSDUCER

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

Patient Problem Perforation of Esophagus (2399)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

We will file a follow-up mdr if more information is received.Reference complaint # (b)(4).

Event Description

It was reported that a female patient who was diagnosed with severe mitral valve insufficiency, underwent a transesophageal echocardiogram (tee).The patient was administered general anaesthesia peri procedure.The were no issues encountered during the procedure; however, at the conclusion of the case, the patients' esophagus was reported to have ruptured and the tear was 25 cm long.The cardiologist stated that the v5ms transducer may have contributed to the injury.The patient was immediately taken to surgery and underwent an interventional closed-tube thoracostomy with esophagus raffia and placement of mediastinal drainage pipes.The patient was provided additional general mono brachial medication to extend sedation because the required intervention had lasted 90 minutes.Following the surgery, it was reported that the patient was doing well and there was no patient clinical sequela.No additional information was provided.

Manufacturer Narrative

Evaluation summary: the transducer was returned for analysis, and engineering confirmed it passed all the mechanical functions, leakage, and conductivity tests.No mechanical defects (internally or externally) could be found on the transducer that could have caused/contributed to the esophageal rupture reported by the customer.Reference: (b)(4).

Manufacturer Narrative

Corrected conclusion code.After further evaluation of the investigation results, it was determined there was no mechanical defect of the transducer that could have caused/contributed to an esophageal rupture, and the adverse event was reclassified as not reportable.Reference: (b)(4).

• Brand Name: SIEMENS ACUSON V5MS TRANSDUCER
• Type of Device: DIAGNOSITIC DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view CA 94043 4050
• MDR Report Key: 7844047
• MDR Text Key: 119116694
• Report Number: 3009498591-2018-00038
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K121807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: V5MS TRANSDUCER
• Device Catalogue Number: 11013704
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 62