MAUDE Adverse Event Report: SAVI®.APPLICATOR TRAY; RADIONUCLIDE APPLICATOR

Model Number	SAVI-10/B
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that post radiology procedure on (b)(6) 2021, the physician attempted to collapse and remove an applicator device from the patient's breast.When attempting to collapse the device the number 1 catheter broke loose at the distal end.The physician was unable to collapse the device for removal.The patient was referred to the surgeon's office for successful removal.No additional consequences to report.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed and the root cause is attributed to clinical use and excessive force during use.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: SAVI®.APPLICATOR TRAY
• Common Device Name: RADIONUCLIDE APPLICATOR
• MDR Report Key: 12050067
• Report Number: 1721504-2021-00042
• Device Sequence Number: 11852073
• Product Code: JAQ
• UDI-Device Identifier: 00884450434291
• UDI-Public: 884450434291
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K081677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: SAVI-10/B
• Device Lot Number: H1689864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 08/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention