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

Model Number	G21363
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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?.
Additional Manufacturer Narrative
Blank fields on this form indicated the information is unknown, unchanged, or unavailable.The complaint/event that was entered and reported within trackwise: "strand broke, probe remains in patient." per complaint information/attachments/communication, it was stated that the device (probe) was used on a patient along with the device is in the patient.It was also stated that the instructions for use were addressed and to let the surgeon know the metal wire part of the probe has not been tested for mri compatibility, while any of the wire is present within the patient.The device was not returned for the complaint; therefore, a physical investigation could not be performed, and the customer's complaint could not be confirmed, other than by the customer's testimony.The device history record (dhr) was reviewed.There were no signs that the device was nonconforming or that the device was not manufactured to current specifications.This complaint mode will be tracked, trended and monitored in cvi complaint handling and post market surveillance procedures.A risk assessment will be performed within the complaint summary tab of trackwise.G5 ¿ pma/510(k): (b)(6).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 or Problem 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?.
Event or Problem 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?.
Additional Manufacturer Narrative
Blank fields on this form indicated the information is unknown, unchanged, or unavailable.Corrected/updated data 03sep2024 ahe per the following d4 - udi: the udi information per 21cfr 803.52(c)(4) and 21 cfr 803.50(b) that is required has been added/updated to this report: d4 model: g21363.G5 ¿ pma/510(k): k171272 the complaint/event that was entered and reported within trackwise: "strand broke, probe remains in patient." per complaint information/attachments/communication, it was stated that the device (probe) was used on a patient along with the device is in the patient.It was also stated that the instructions for use were addressed and to let the surgeon know the metal wire part of the probe has not been tested for mri compatibility, while any of the wire is present within the patient.The device was not returned for the complaint; therefore, a physical investigation could not be performed, and the customer's complaint could not be confirmed, other than by the customer's testimony.The device history record (dhr) was reviewed.There were no signs that the device was nonconforming or that the device was not manufactured to current specifications.This complaint mode will be tracked, trended and monitored in cvi complaint handling and post market surveillance procedures.A risk assessment will be performed within the complaint summary tab of trackwise.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.

• Brand Name: COOK-SWARTZ DOPPLER PROBE
• Common Device Name: 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
• Report Number: 2522007-2024-00013
• Device Sequence Number: 14189676
• Product Code: ITX
• UDI-Device Identifier: 00827002213630
• UDI-Public: (01)00827002213630(17)261130(10)N200708
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2024

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
• Operator of Device: Health Professional
• Device Model Number: G21363
• Device Catalogue Number: DP-SDP001
• Device Lot Number: N200708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 06/10/2024; 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2023
• 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 Age: 58 YR
• Patient Sex: Female