MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. SYNGO MRI INTERFACE; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 11/04/2016

Event Type  malfunction  

Event Description

Male patient with history of prostate adenocarcinoma, stage iv.Initially was diagnosed approximately 17 years ago, and status post (s/p) prostatectomy with salvage radiation therapy.The patient also received hormonal therapy for salvage treatment with rising psa levels bone scan approximately 17 months ago, demonstrated increased radiotracer uptake in right mid to distal tibia, strongly suggestive of blastic metastasis.Systemic treatment continued.The patient presented to his medical oncologist with intermittent right lower tibia pain (10/10 at worst).Follow up x-ray of his right lower leg approximately one year ago was abnormal.Pmh/psh: urethral stricture, prostatectomy, ureteral stent x5, nephrostomy, cataract removal the patient was imaged on the mobile mri unit on approximately 10 months ago by 2 mri techs.One tech attended to the patient, the second tech attended to the siemens mri screen.Prior films not available for reference.During mri registration, the patient orientation (in the scanner) was selected incorrectly as prone rather than supine.(prone selection directly under supine selection).Per protocol, a vitamin e capsule was placed (taped) by the staff/patient on the correct (right) leg.The flexible coil was wrapped around right leg.The patient went into the mri scanner supine and feet first.Imaging sequence performed.Image of the localizer not saved in pacs (tech was told recently that it was no longer necessary).The mri tech attending to the scanner was focused on finding the tumor on the scan and did not notice the discrepancy in the anatomy.The quality of the image was not as clear as it could have been, but the tech had recalled seeing similar quality scans in the past.The original interpreting radiologist did not notice the discrepancy.Mri low ext w/wo cont rt.Comparison: none available.Correlation: right tibia and fibula films of approximately 7 weeks earlier.Technique: axial t1, fat-suppressed t2, pre-and postcontrast fat-suppressed t1, coronal and sagittal t1, ir and postcontrast fat-suppressed t1.Ten cc iv multihance.Impression: no evidence of osseous metastasis involving the right tibia or fibula.No evidence of acute fracture or subluxation.Approximately 7 weeks later: the event was not identified, until the chart was randomly selected for imaging peer review.Subsequently, an addendum to the original interpretation/findings will be made by original interpreting radiologist: the mri images have been re-reviewed.The order was for an mri of the right lower extremity.It was noted that the mri was conducted on the left lower extremity.Recommend patient to have mri of right lower extremity.The findings were discussed with ordering physician.Approximately 8 weeks after earlier mri - patient returns for mri of right leg.Abnormal finding impression: metastasis (1st paragraph) and consequent reactive change (2nd paragraph).Osteonecrosis (3rd paragraph).Consult for palliative radiation therapy.Diagnosis: prostate adenocarcinoma metastatic to right tibia, stage iv.

Event Description

Male patient with history of prostate adenocarcinoma, stage iv.Initially was diagnosed approximately 17 years ago, and status post (s/p) prostatectomy with salvage radiation therapy.The patient also received hormonal therapy for salvage treatment with rising psa levels bone scan approximately 17 months ago, demonstrated increased radiotracer uptake in right mid to distal tibia, strongly suggestive of blastic metastasis.Systemic treatment continued.The patient presented to his medical oncologist with intermittent right lower tibia pain (10/10 at worst).Follow up x-ray of his right lower leg approximately one year ago was abnormal.Pmh/psh: urethral stricture, prostatectomy, ureteral stent x5, nephrostomy, cataract removal the patient was imaged on the mobile mri unit on approximately 10 months ago by 2 mri techs.One tech attended to the patient, the second tech attended to the siemens mri screen.Prior films not available for reference.During mri registration, the patient orientation (in the scanner) was selected incorrectly as prone rather than supine.(prone selection directly under supine selection).Per protocol, a vitamin e capsule was placed (taped) by the staff/patient on the correct (right) leg.The flexible coil was wrapped around right leg.The patient went into the mri scanner supine and feet first.Imaging sequence performed.Image of the localizer not saved in pacs (tech was told recently that it was no longer necessary).The mri tech attending to the scanner was focused on finding the tumor on the scan and did not notice the discrepancy in the anatomy.The quality of the image was not as clear as it could have been, but the tech had recalled seeing similar quality scans in the past.The original interpreting radiologist did not notice the discrepancy.Mri low ext w/wo cont rt comparison: none available.Correlation: right tibia and fibula films of approximately 7 weeks earlier.Technique: axial t1, fat-suppressed t2, pre-and postcontrast fat-suppressed t1, coronal and sagittal t1, ir and postcontrast fat-suppressed t1.10 cc iv multihance.Impression: no evidence of osseous metastasis involving the right tibia or fibula.No evidence of acute fracture or subluxation.Approximately 7 weeks later: the event was not identified, until the chart was randomly selected for imaging peer review subsequently, an addendum to the original interpretation/findings will be made by original interpreting radiologist: the mri images have been re-reviewed.The order was for an mri of the right lower extremity.It was noted that the mri was conducted on the left lower extremity.Recommend patient to have mri of right lower extremity.The findings were discussed with ordering physician.Approximately 8 weeks after earlier mri - patient returns for mri of right leg.Abnormal finding.Impression: metastasis (1st paragraph) and consequent reactive change (2nd paragraph).Osteonecrosis (3rd paragraph).Consult for palliative radiation therapy.Diagnosis: prostate adenocarcinoma metastatic to right tibia, stage iv.

• Brand Name: SYNGO MRI INTERFACE
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 2501 north barrington rd.; hoffman est IL 60192
• MDR Report Key: 6847819
• MDR Text Key: 85113749
• Report Number: 6847819
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/04/2017
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/04/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 74 YR