MAUDE Adverse Event Report: GALT MEDICAL CORPORATION MICRO-INTRODUCER KIT; 4F MICRO-INTRODUCER KIT, PACKAGED STERILE FOR B BRAUN 610373

Model Number	KIT-018-61
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not available for evaluation and it was discarded by end user.Investigation conducted based on dhrs review; documentation shows there was no abnormality or nonconformance recorded during manufacturing process.Based on complaint or event description received from end user, the wire met a resistance then it was removed while the needle was still in the position and this is where the wire will be sheared off when retrieving the wire over the needle.Also, there were multiple insertion attempts with the wire while the needle was in position.Ifu indicate; do not withdraw the guidewire back into the cannula as this may result in separation of the guidewire.The introducer cannula should be removed first.If the guidewire must be withdrawn while needle is inserted, remove both the needle and the wire as a unit to prevent the needle from damaging or shearing of the guidewire.The cannula must be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 by manufacturer from end user/sales rep.The guidewire broke in the patient as it was being used, and the piece could not be retrieved.Using the 4fr micro[?]puncture kit, flexible tip wire was passed through the wire and met resistance.The wire was removed and the access needle angle was changed slightly without removing vein access and maintaining aspiration of venous blood.The flexible tip wire was passed again and met resistance.It was easily removed, but on examination and fluoroscopy it was noted that the tip had sheared off.Multiple fluoroscopic images demonstrated a fixed wire tip in the location medial to the subclavian or internal jugular veins.

• Brand Name: MICRO-INTRODUCER KIT
• Common Device Name: 4F MICRO-INTRODUCER KIT, PACKAGED STERILE FOR B BRAUN 610373
• Manufacturer (Section D): GALT MEDICAL CORPORATION; 2220 merritt dr #100; garland TX 75041
• MDR Report Key: 11374165
• Report Number: 1649395-2021-00001
• Device Sequence Number: 3882320
• Product Code: DQX
• UDI-Device Identifier: 04046964327483
• UDI-Public: 04046964327483
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 02/24/2021

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: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: KIT-018-61
• Device Catalogue Number: 610373
• Device Lot Number: P20071029
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 02/24/2021
• 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