MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) INTACT GEN1 WAND 20 MM; INSTRUMENT, BIOPSY

Model Number 777-120BT

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

Product event: (b)(4).Patient information incomplete and missing patient information unable to be obtained despite a good faith effort made to obtain the information from the customer.If information is provided in the future, a supplemental report will be issued.

Event Description

During a breast lesion excision system case, the intact wire basket fractured and detached from the device.The detached wire remained in the patient, however there was no patient adverse effect reported.

Manufacturer Narrative

Product analysis #(b)(4): brief description of complaint: the wire basket broke during activation.This was the second of two cases that were reported by the facility via e-mail.Per e-mail the lesion was not removed, the wire broke into the breast and a piece was left in.Analysis conclusion: complaint confirmed: there are four wire breaks within the multileaf element, however, it cannot be determined how or when the wire segments became damaged.There are three eyelets that are broken and missing within the multileaf element and there are two eyelets that are folded over but remain attached to the leaves.If information is provided in the future, a supplemental report will be issued.

Event Description

During a breast lesion excision system case, the intact wire basket fractured and detached from the device.The detached wire remained in the patient, however there was no patient adverse effect reported.

• Brand Name: INTACT GEN1 WAND 20 MM
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer Contact: kaylee boisvert ; 180 international drive; portsmouth, NH 03801 ; 6038426234
• MDR Report Key: 7266147
• MDR Text Key: 99898896
• Report Number: 1226420-2018-00042
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K142477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Model Number: 777-120BT
• Device Catalogue Number: 777-120BT
• Device Lot Number: EIT20E01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 02/13/2018
• Supplement Dates Manufacturer Received: 03/02/2018
• Supplement Dates FDA Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 46 YR
• Patient Weight: 56