MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC. MAMMOMARK BIOPSY SITE INDENTIFIERS; BIOPSY SITE MARKER

Model Number MRM4008

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 03/19/2015

Event Type  malfunction  

Event Description

The sales rep has reported mri procedure where the cube was falling out, the targeting set was incredibly difficult to insert and the first attempted marker pulled right back out with deployment rod after 180 rotation.Cube and targeting set were discarded.Patient complications indicated as long procedure, bigger than usual skin incision as the doctor kept inserting the scalpel, as well as potential inaccuracy of the bx and marker as she eventually gave up on the targeting set, pulled that out and inserted probe independently of that.

Manufacturer Narrative

(b)(4).Investigation summary: two complaints were initiated for this single event as 2 products were impacted.(b)(4) is discussed further in medwatch rep # (b)(4).This report is specific to (b)(4).Device has not yet been received for analysis.However, the marker deployment issue described for the mrm4008 product code was most likely caused by the malfunction of the mr targeting set, product code mru082, rather than of the marker device use and/or functionality.Additional analysis of this event is in progress.

Manufacturer Narrative

Complaint reference number: (b)(4).The investigation was not complete at time of initial reporting; the investigation summary is provided here.On 04/29/2015, an mrm4008 from lot f11420225d1 was received from the customer for evaluation.The mrm4008 was received in good condition and showed evidence of having been used in a procedure.Marker had been deployed.No evidence of product malfunction.The dhr for this lot was reviewed.No anomalies noted.An analysis of the last three production lots for the mru08s targeting set, which includes the cube accessory, was completed on 05/28/2015.No anomalies were noted.All specifications were met, within defined tolerances and capabilities.The cube helps to stabilize the targeting set used in an mr procedure.However, instances of loose cube have been observed during procedures where physicians use a free-hand technique and/or breast tissue is dense.Based on a clinical review of this event, it is likely that physician technique and tissue density were contributors to the event.

• Brand Name: MAMMOMARK BIOPSY SITE INDENTIFIERS
• Type of Device: BIOPSY SITE MARKER
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC.; 300 e-business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS INC.; 300 e business way; fifth floor; cincinnati OH 45241
• Manufacturer Contact: shawna rose ; 5138649178
• MDR Report Key: 4711738
• MDR Text Key: 5648312
• Report Number: 3008492462-2015-00004
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 03/19/2015

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: 11/01/2015
• Device Model Number: MRM4008
• Device Catalogue Number: MRM4008
• Device Lot Number: F11420225D1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/29/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 04/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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): Other