MAUDE Adverse Event Report: GALT MEDICAL CORPORATION 6F HYDROPHILIC GALTSTICK INT KIT

Model Number	KIT-036-06
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint received by manufacturer (galt medical) from fda by mail.End user sent mdr med watch report to fda under report number (b)(4) about guidewires broke inside the patient.The manufacturer (galt medical) created complaint record number (b)(4) and notified end user about this record and requesting complaint sample to be returned for evaluation.At this moment investigation and evaluation performed on documentation and complaint history review and there are no incidents or abnormality indicated during manufacturing process.All products and/or subcomponents manufactured to specification and pass inspections per applicable criteria.Galt create rma for end user to return the sample and once complaint sample return then galt will complete investigation and evaluation and a follow-up report will send to fda reference to this report.
Event or Problem Description
Manufacturer (galt medical) received med watch report 3500a form by mail from fda on 6/30/2021.End user stating that during removal of double j urinary stent a piece of galtstick lot number (g21012090) 0.018 wire broke off inside the patient's right kidney.Md attempted and took approximately 2 hours to snare and remove this piece - unsuccessfully.Wire remained inside patient at conclusion of procedure.At this time the manufacturer (galt medical) does not have any other information regarding patient status and additional information requested from end user to be provided to galt medical to help with investigation and evaluation.

• Brand Name: 6F HYDROPHILIC GALTSTICK INT KIT
• Common Device Name: GALTSTICK INT KIT
• Manufacturer (Section D): GALT MEDICAL CORPORATION; 2220 merritt dr #100; garland 75041
• MDR Report Key: 12124446
• Report Number: 1649395-2021-00006
• Device Sequence Number: 3325088
• Product Code: DQX
• UDI-Device Identifier: 20841268105793
• UDI-Public: 20841268105793
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2021

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: No Information
• Device Expiration Date: 03/01/2025
• Device Model Number: KIT-036-06
• Device Lot Number: G21012090
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR