MAUDE Adverse Event Report: MAMMOTOME; BOWTIE CLIP FOR BREAST BX

Lot Number F11820480D

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Failure of Implant (1924)

Event Date 08/01/2018

Event Type  malfunction  

Event Description

Patient came in for a right breast biopsy of several areas, x5 clips were placed in the right breast.The post mammo only showed x4 clips.The bowtie clip was not visualized.After explaining to the patient that the clip was not visualized, patient was brought back into the biopsy suite and another clip was placed.After another post mammo, the bowtie clip was again not visualized.Pt brought back again and an x-clip was placed.After another post mammo, x5 clips were visualized from the 5 areas of biopsy.

• Type of Device: BOWTIE CLIP FOR BREAST BX
• Manufacturer (Section D): MAMMOTOME; 300 e-business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 8573074
• MDR Text Key: 143818856
• Report Number: 8573074
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: F11820480D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2019
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1