MAUDE Adverse Event Report: GALT MEDICAL CORP. MICRO-INTRODUCER KIT; 4F TRANSITIONLESS MICRO-INTRODUCER KIT W/MARKED GWA & NDL (SILK ROAD)

Model Number KIT-075-01

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Vascular Dissection (3160)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned by hospital/end user, investigation performed on device history record review and complaint history record review.

Event Description

Dissection was noticed following post-dilation of stent at proximal edge and extending posterior to stent.A 8x50 viabahn stent was placed to cover the dissection.Dissection was thought to have occurred at the.014 wire crossing but after review it could have occurred at time of the galt micropuncture kit (mpk), but it is thought not to have based on cca length, so therefore it is unknown if the dissection was caused by the mpk or the.014 wire.

• Brand Name: MICRO-INTRODUCER KIT
• Type of Device: 4F TRANSITIONLESS MICRO-INTRODUCER KIT W/MARKED GWA & NDL (SILK ROAD)
• Manufacturer (Section D): GALT MEDICAL CORP.; 2220 merritt dr; garland TX 75041
• Manufacturer (Section G): GALT MEDICAL CORP; 2220 merritt dr; garland TX 75041
• Manufacturer Contact: diyar medhat ; 2220 merritt dr; garland, TX 75041 ; 9722715177
• MDR Report Key: 7108387
• MDR Text Key: 94995484
• Report Number: 1649395-2017-00006
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 10841268106939
• UDI-Public: (01)10841268106939
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 11/09/2017

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
• Device Operator: No Information
• Device Expiration Date: 08/28/2021
• Device Model Number: KIT-075-01
• Device Lot Number: G17201706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2017
• Distributor Facility Aware Date: 11/14/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2017
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other