MAUDE Adverse Event Report: SOMATEX MEDICAL TECHNOLOGIES GMBH TULOC

Model Number	271661
Medical Device Problem Codes	Material Fragmentation (1261); Use of Device Problem (1670)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023, after a breast biopsy the physician attempted to implant a tuloc harpoon, the physician reported that he had to readjust the harpoon and on the control mammogram it was observed a small cylinder inside the breast that had detached from the harpoon.The physician verified the proper functioning of the harpoon before using it.During tracking he removed the harpoon to readjust its position without any particular technical problem.However on the follow up mammogram it was found that a 17mm linea metal was stuck inside the breast.It was not there before removal.The harpoon was checked and a small cylindral piece was missing from the end of the wire.The device was returned for examination and it was confirmed that a small piece was missing from the end section of the deployer.A follow up with the physician revealed that the patient was not affected by the procedure and in a subsequent surgery already planed to remove the pathology the metal cylinder was removed as well.No more tissue required to be removed from the patient and no additional medical intervention required.A follow up mammogram is scheduled for (b)(6) 2023.No other information is available.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.The investigation revealed that a user error led to the incident.The error pattern can be generated by 2 possible misapplications.The user pushed the wire too far out of the cannula (together with the glued metal tube) or the user pulled the cannula back to remove it after the wire was released.  in both cases, the wire is released and the glued metal tube is in front of the cannula tip.Then the user pulled the wire back into the cannula as mentioned in the complaint information email.This caused the glued metal tube to wedge on the cannula tip and come off.The metal tube is glued to the wire, but not too much force is needed to loosen it.  the instructions for use states that the wire should only be pushed into the cannula until the last visible marking on the wire has been inserted into the cannula hub.  furthermore, it is stated in the ifu that repositioning of the wire should only be done before pulling out the cannula.One of these two instructions in the ifu was not followed by the user when using the product.
Additional Manufacturer Narrative
A follow up mammogram was performed on the patient and he mammogram done today confirms that the metal piece was completely removed intraoperatively.A control mammogram also confirmed this.And no additional intervention was necessary.

• Brand Name: TULOC
• Common Device Name: TULOC
• Manufacturer (Section D): SOMATEX MEDICAL TECHNOLOGIES GMBH; hohenzollerndamm 150/151; berlin, 14199 ; GM 14199
• Manufacturer (Section G): SOMATEX MEDICAL TECHNOLOGIES GMBH; hohenzollerndamm 150/151; berlin, 14199 ; GM 14199
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose, alajuela 20102- CRI ; CS 20102 CRI
• MDR Report Key: 16742843
• Report Number: 1000408433-2023-00002
• Device Sequence Number: 6539512
• Product Code: MIJ
• UDI-Device Identifier: 04250195600844
• UDI-Public: 04250195600844
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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 Model Number: 271661
• Device Catalogue Number: 271661
• Device Lot Number: 52193
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female