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

Catalog Number SAVI-10/B

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/16/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device was not returned.A complete investigation could not be performed.A lot number was reported, and a review of the manufacturing history record is in progress.Should the device be returned at a later date, the investigation will be re-opened.

Event Description

The account alleges that during an accelerated partial breast irradiation (apbi) procedure on (b)(6) 2021, the brachytherapy device was implanted and deployed to deliver radiation directly to the lumpectomy site for the patient.The catheters expand to fit the size and shape of the tumor cavity.Catheter #1 on the brachytherapy bundle device broke 6cm from the distal end.The account alleges that there was not enough catheter extending beyond the handle to attach the transfer guide tube.A new treatment plan was initiated without the #1 catheter and the 9th fraction was completed.The 10th and last fraction was completed on the afternoon of (b)(6) 2021.The account alleges that during an attempt to remove the brachytherapy bundle device, the expansion tool detached from the distal end.The physician was unable to collapse the device for removal.The patient was sent to a surgeon's office for device removal.The incision site was enlarged, and the brachytherapy bundle device was successfully removed.A penrose drain was placed, and the incision site was closed with proline sutures.The patient was sent home with no additional consequences to report.

Manufacturer Narrative

The suspect device was not returned for evaluation however photographs of the suspect unit were provided.The complaint was confirmed based on the photographs provided.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints with this lot number were identified.Should the device be returned at a later date, the investigation will be re-opened.

• Brand Name: SAVI®.APPLICATOR TRAY
• Type of Device: REMOTE CONTROLLED RADIONUCLIDE APPLICATOR SYSTEM.
• MDR Report Key: 11784268
• MDR Text Key: 249288635
• Report Number: 1721504-2021-00028
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• 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 Catalogue Number: SAVI-10/B
• Device Lot Number: H1689864
• Date Manufacturer Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention