MAUDE Adverse Event Report: GALT MEDICAL CORP TORX GUIDEWIRE; 0.014 X 300CM NITI / GOLD W/ 5CM ANGLED TIP

Model Number	SGW-038-07
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history records were reviewed for main product and subcomponents and there are no incidents or abnormality has been recorded, all parts have been manufactured to specifications.One sample was returned and some pictures were taken.Photos taken for complaint sample shows the guidewire was broken from the tip where the wire being tapered (approximately 6cm of core wire from distal tip) and coiled gold wire broke off and separated from the tip as well (this portion did not returned with complaint sample and probably disposed by end user after retrieved from patient body).Galt engineering team has completed investigation on (sgw-038-07) 0.014" x 300cm niti / gold w/ 5cm angled tip, manufactured at galt medical corp here in (b)(4).The evaluation showed all samples were manufactured to specification according to engineering drawings and the design requirement.The manufacturing documentations indicates that the purchased materials passed galt incoming inspections requirements, and the dhrs, drawing confirmed all parts were manufactured to specifications without any abnormality or deviations indicated.The information below was acquired from random selected samples for subcomponent crw-010-14 and finished good gwa-038-07 found in galt inventory: distal tip flatten end thickness was within specifications of 0.003" per galt design controls.Tensile pull force for ball weld joint at distal tip is higher than minimum required per engineering drawings and iso: 11070-2014.(galt min.(b)(4)), and average results was ((b)(4)).Average tensile pull force @ 1cm from uncoiled distal tip core wire without ball weld joint was (b)(4).Average tensile pull force @ 4cm from uncoiled distal tip core wire without ball weld joint was (b)(4).Average torqueability for random selected coiled tip samples was 18.7 revolutions @360 degree that required breaking core wire.This investigation provide evidence that galt manufactured the 0.014" x 300cm niti / gold w/ 5cm angled tip in accordance to the specification and galt does not have any history of non-conformances related to the process or design of gwa-038-07 which is used in the finished sterile sgw-038-07.Possible root cause for this type of incident based on complaint history record was end user did not follow instructions per ifu the stated.The device was submitted to over torque and caused broke off distal tip of coiled part along with the core portion.Recommendations has sent to customer and end user through galt failure investigation report stating that: "warnings": "do not withdraw guidewire through metal needles; guidewire may shear or unravel" "warnings": "do not rotate the guidewire if significant resistance is felt".
Event or Problem Description
As received from end user (using the wire for intervention rt join to tp trunk of left leg.Several attempts to pass lesion, wire tip broke off.Results was prolonged intervention with foreign body retrieval needed).

• Brand Name: TORX GUIDEWIRE
• Common Device Name: 0.014 X 300CM NITI / GOLD W/ 5CM ANGLED TIP
• Manufacturer (Section D): GALT MEDICAL CORP; 2220, 6137, merritt dr; garland TX 75041
• MDR Report Key: 8325511
• Report Number: 1649395-2019-00002
• Device Sequence Number: 16577943
• Product Code: DQX
• UDI-Device Identifier: 20841268101184
• UDI-Public: 20841268101184
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K021990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2019
• Report Date (Section F): 01/16/2019

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: 01/28/2022
• Device Model Number: SGW-038-07
• Device Catalogue Number: SGW-038-07
• Device Lot Number: G18033156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/16/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/11/2019
• 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