MAUDE Adverse Event Report: GALT MEDICAL CORP GALT MICRO-INTRODUCER KIT

Model Number	KIT-002-08
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 09/11/2019 manufacturer received medwatch report from fda by mail under report number (mw5089045).Manufacturer creates complaint record under report number 2018.Documentation and dhr has been reviewed for main product and subcomponents and there no incidents or abnormality detected.All samples manufactured to specification according to eng dwg.Manufacturer will make addendum to original failure investigation report once complaint sample returned from end user or hospital.Manufacturer will evaluate defect sample and address corrective action and recommendations if needed.A follow up report will be send to fda once final failure investigation report completed.
Event or Problem Description
As received by mail under fda medwatch report no.(mw5089045), patient presented for thrombosis of arteriovenous graft.Micropuncture wire broke but was retrieved in its entirety.
Event or Problem Description
As received by mail under fda medwatch report no.(mw5089045), patient presented for thrombosis of arteriovenous graft.Micropuncture wire broke but was retrieved in its entirety.
Additional Manufacturer Narrative
On 09/11/2019 manufacturer received medwatch report from "fda" by mail under report number (mw5089045).Manufacturer creates complaint record under report number (b)(4).Documentation and dhr has been reviewed for main product and subcomponents and there no incidents or abnormality detected.All samples manufactured to specification according to eng dwg.Manufacturer will make addendum to original failure investigation report once complaint sample returned from end user or hospital.Manufacturer will evaluate defect sample and address corrective action and recommendations if needed.A follow up report will be send to fda once final failure investigation report completed.Additional investigation: one sample was returned, but the complaint can't be confirmed.Galt took some photos for returned sample as shown below.Returned sample was missing a piece of wire that retrieved from patient body, the core wire was broken about 3cm towards distal tip direction.The ball weld might be damaged/broke during extraction of the guidewire over the needle or the wire might submit to overtorque.Possible root cause for this occurrence end user did not follow ifu lab-021-00 root cause: possible root cause determined to be end user error.Recommendations: adhere to ifu.

• Brand Name: GALT MICRO-INTRODUCER KIT
• Common Device Name: MICRO-INTRODUCER KIT
• Manufacturer (Section D): GALT MEDICAL CORP; 2220 merritt dr #6137; garland TX 75041
• MDR Report Key: 9079647
• Report Number: 1649395-2019-00005
• Device Sequence Number: 1951360
• Product Code: DQX
• UDI-Device Identifier: 20841268104734
• UDI-Public: 20841268104734
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K021990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019
• Report Date (Section F): 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 03/28/2023
• Device Model Number: KIT-002-08
• Device Lot Number: G19067254
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/11/2019
• Device Age: 5 MO
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/17/2019