MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 SURE-POINT® TRACKER; TRACKER CONTROL BOX

Model Number	D0136200
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the tracker control box's linear encoder was not working.When advancing, the device would not show images.Per additional information received on (b)(6) 2019, a male patient was undergoing a rectal ultrasound guided probe for preplanning of brachytherapy seed mapping and placement.The device would not display images of the prostate gland.The physician had to collect manual images and this extended the patient's procedure under conscious sedation.The patient did not incur any injury due to the extended procedure time and conscious sedation time.The device was sent to the biomed for evaluation.
Additional Manufacturer Narrative
The reported event was confirmed.During the evaluation, the encoder cable had a short hence it was not functioning.A potential cause could be user-related as there are various controls in place prior to its shipment.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "encoders should never be cleaned with a water spray or immersion to avoid damage.".
Event or Problem Description
It was reported that the tracker control box's linear encoder was not working.When advancing, the device would not show images.Per additional information received on 12sep2019, a male patient was undergoing a rectal ultrasound guided probe for preplanning of brachytherapy seed mapping and placement.The device would not display images of the prostate gland.The physician had to collect manual images and this extended the patient's procedure under conscious sedation.The patient did not incur any injury due to the extended procedure time and conscious sedation time.The device was sent to the biomed for evaluation.

• Brand Name: SURE-POINT® TRACKER
• Common Device Name: TRACKER CONTROL BOX
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 9146390
• Report Number: 1018233-2019-06166
• Device Sequence Number: 16901877
• Product Code: ITX
• UDI-Device Identifier: 00801741078897
• UDI-Public: (01)00801741078897
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K030518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

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 Model Number: D0136200
• Device Catalogue Number: D0136200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other