MAUDE Adverse Event Report: GALT MEDICAL CORP USEGS14-300A; NITINOL MANDREL TIP (AU) ANGLED

Model Number	SGW-060-01
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not saved for analysis.Investigation and evaluation performed based on dhr review and complaint history review.Documentation shows all parts have been manufactured to specifications and passed inspection criteria per applicable drawing and requirements.Complaint history record was reviewed for complaints related to guidewires and there are (31) records in galt quality system during last five years related to guidewires complaint.(15) records shows that wires were cut or frayed or tangled during procedure and evaluation for all these records shows the possible root cause was end user error/end user did not followed instructions per ifu.Most of the rest of records shows no samples were available for evaluation and then complaint cannot be confirmed.Only (3) records shows the complaint related to manufacturer human factor error and the complaint detected at customer site prior use by end user.
Event or Problem Description
As received from customer by end user: 5cm gold tip broke off in the patient as wire was turned to navigate the vessel, wire tip broke off in the patient while positioning down the leg.Approx.5cm of wire remains in the patient and was stented/pinned to the vessel wall.Action taken by physician was stented / pinned wire tip to vessel wall and the adverse event was resolved.

• Brand Name: USEGS14-300A
• Common Device Name: NITINOL MANDREL TIP (AU) ANGLED
• Manufacturer (Section D): GALT MEDICAL CORP; 2220, 6137, merritt dr; garland TX 75041
• MDR Report Key: 7936758
• Report Number: 1649395-2018-00009
• Device Sequence Number: 16711698
• Product Code: DQX
• UDI-Device Identifier: 20841268100484
• UDI-Public: 20841268100484
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K021990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other,user facili
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2018
• Report Date (Section F): 10/01/2018

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: 04/28/2022
• Device Model Number: SGW-060-01
• Device Catalogue Number: USEGS114-300A
• Device Lot Number: G18141006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/04/2018
• 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
• Patient Age: 88 YR