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

Model Number SAVI-10/B

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event 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.

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
• Type of Device: RADIONUCLIDE APPLICATOR
• MDR Report Key: 12050067
• MDR Text Key: 257748525
• Report Number: 1721504-2021-00042
• Device Sequence Number: 1
• Product Code: JAQ
• UDI-Device Identifier: 00884450434291
• UDI-Public: 884450434291
• Combination Product (y/n): N
• PMA/PMN Number: K081677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2020
• 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
• Patient Outcome(s): Required Intervention