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
Health Effect - Clinical Code	Vascular Dissection (3160)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 4F TRANSITIONLESS MICRO-INTRODUCER KIT W/MARKED GWA & NDL (SILK ROAD)
• Manufacturer (Section D): GALT MEDICAL CORP.; 2220 merritt dr; garland TX 75041
• MDR Report Key: 7108387
• Report Number: 1649395-2017-00006
• Device Sequence Number: 13755551
• Product Code: DQX
• UDI-Device Identifier: 10841268106939
• UDI-Public: (01)10841268106939
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K021990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring,Inspection,Notification
• Type of Report: Initial
• Report Date (Section F): 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
• Operator of Device: No Information
• Device Expiration Date: 08/28/2021
• Device Model Number: KIT-075-01
• Device Lot Number: G17201706
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/14/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/12/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 11/09/2017