MAUDE Adverse Event Report: COOK VANDERGRIFT INC COOK-SWARTZ DOPPLER PROBE; ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Catalog Number DP-SDP001

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/18/2024

Event Type  Injury  

Manufacturer Narrative

Lank fields on this form indicated the information is unknown, unchanged, or unavailable.The event is currently under investigation.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available or upon completion of investigation.D2b ¿ product code: itx.G5 ¿ pma/510(k): this report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

As initially reported to customer relations: gentle traction was used on the wire at the point of entry to the skin.The left breast probe was removed without incidence but the on the right side, it appears that one strand of the braided wire came out fully (but without the crystal probe) and the other strand broke.Each time the broken strand was grabbed it broke.Xray does not show the wire.Obviously there is significant risk in trying to go back and remove the probe surgically.Given, the findings of the article i have included, what is the basis for the company¿s recommendation to surgically remove the wire?.

• Brand Name: COOK-SWARTZ DOPPLER PROBE
• Type of Device: ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer (Section G): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: timothy vogel ; 1186 montgomery lane; vandergrift, PA 15690 ; 7248458621
• MDR Report Key: 18990995
• MDR Text Key: 338886865
• Report Number: 2522007-2024-00013
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)261130(10)N200708
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DP-SDP001
• Device Lot Number: N200708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2023
• 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
• Patient Age: 58 YR
• Patient Sex: Female