MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC MAMMOTOME REVOLVE STEREOTACTIC PROBE; BIOPSY INSTRUMENT

Model Number	MST1012
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mst1012 probes are sterile, single use devices, indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.It was reported via medwatch voluntary event report that stereotactic left breast biopsy was performed.A 12 cm, 10 gauge mammotome revolve needle was inadvertently loaded in mammotome instead of a 9 cm, 10 gauge needle.Post biopsy images showed a 4 mm v shaped retained metallic fragment in left breast.Inspection of the needle showed a damaged cannula at the tip.Patient was immediately referred to breast clinic and seen by breast surgeon.Patient scheduled for elective surgery for removal of breast lesion/calcifications and retained metallic fragment/foreign body.Based on the description of the event provided in fda report mw5095843, it is believed that the customer entered the incorrect product code information in to the stereotactic targeting dimensions.Upon firing of device, because the user thought they had a 9cm needle (and the actually had a 12cm needle), the extra 3sm length unaccounted for in the targeting software, the needle was able to be fired past the zero point and into the bucky of the stereotactic brest imaging table.Firing into the bucky is sufficient force to break off the tip of the needle of the stereotactic biopsy device, embedding it into the soft tissue of the patients breast.
Event or Problem Description
It was reported via medwatch voluntary event report that during a stereotactic left breast biopsy procedure, a 12 cm, 10 gauge mammotome revolve needle was inadvertently loaded in mammotome instead of a 9 cm, 10 gauge needle.Biopsy of left breast lesion was performed.Post biopsy images showed a 4 mm v shaped retained metallic fragment in left breast.Inspection of the needle showed a damaged cannula at the tip.Patient was immediately referred to breast clinic and seen by breast surgeon.Patient scheduled for elective surgery for removal of breast lesion/calcifications and retained metallic fragment/foreign body.The original packaging for the probe in question was not kept, nor was the probe.Device was traced back to (b)(6) hospital-(b)(6)(1383998) based off the lot number.

• Brand Name: MAMMOTOME REVOLVE STEREOTACTIC PROBE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC; 300 e. business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 10601577
• Report Number: 3008492462-2020-00008
• Device Sequence Number: 3885462
• Product Code: KNW
• UDI-Device Identifier: 00841911100751
• UDI-Public: (01)00841911100751(17)200831(10)F11732453D
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K152989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: MST1012
• Device Lot Number: F11732453D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 09/29/2020
• 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: Required Intervention