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

Device Problems Break (1069); Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/02/2020

Event Type  malfunction  

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this may result in separation of the guidewire.The introducer cannula should be removed first.If the guidewire must be withdrawn while needle is inserted, remove both the needle and the wire as a unit to prevent the needle from damaging or shearing of the guidewire.The cannula must be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 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
• Type of Device: 4F MICRO-INTRODUCER KIT, PACKAGED STERILE FOR B BRAUN 610373
• Manufacturer (Section D): GALT MEDICAL CORPORATION; 2220 merritt dr #100; garland TX 75041
• Manufacturer (Section G): GALT MEDICAL CORP; 2220 merritt dr #100; garland TX 75041
• Manufacturer Contact: diyar medhat ; 2220 merritt dr #100; garland, TX 75041 ; 9722715177
• MDR Report Key: 11374165
• MDR Text Key: 262927155
• Report Number: 1649395-2021-00001
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04046964327483
• UDI-Public: 04046964327483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other