MAUDE Adverse Event Report: GALT MEDICAL CORP BSW - STERILE PACKAGING OF GUIDEWIRES FOR B. BRAUN; BSW-019-10

Model Number	BSW-019-10
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint sample returned.Dhr has been reviewed and it shows there was no abnormality or nonconformance recorded during manufacturing process.Based on complaint description received from customer/end user "the wire was not advancing then it was pulled back and end of the wire was frayed, and tip was missing".Evaluation on returned sample indicate that end user may remove the guidewire over the needle while the needle was still in place.Pictures for returned samples shows the tip of guidewire broke off and coiled portion has been separated from the tip.The tip was also sheared off and unraveled due to multiple insertion attempts of guidewires over the needle.Ifu stating; do not withdraw the guidewire through metal needles as guidewire may shear or unravel.At no time should guidewire be advanced or withdrawn when resistance is met.Determine cause of resistance before proceeding.Advancing of "j" tip may require a gentle rotating motion.If the guidewire must be withdrawn while needle is inserted, remove both the needle and the wire as a unit to prevent the needle from damaging or shearing of the guidewire.The cannula must be removed first.Possible root cause for this occurrence; end user did not follow ifu.
Event or Problem Description
As received from end user-customer (guidewire broke off upon placement in ij.Upon attempt to insert wire was not advancing, pulled back and end of wire was freayed and tip missing.Retained in patient.Patient outcome, related to event: no harm).

• Brand Name: BSW - STERILE PACKAGING OF GUIDEWIRES FOR B. BRAUN
• Common Device Name: BSW-019-10
• Manufacturer (Section D): GALT MEDICAL CORP; 2220 merritt dr #100; garland TX 75041
• MDR Report Key: 11382071
• Report Number: 1649395-2021-00003
• Device Sequence Number: 3865409
• Product Code: DQX
• UDI-Device Identifier: 04046964328121
• UDI-Public: 04046964328121
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K021990
• 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): 02/25/2021

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: 04/28/2024
• Device Model Number: BSW-019-10
• Device Catalogue Number: 610410
• Device Lot Number: P20133069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other