MAUDE Adverse Event Report: GALT MEDICAL CORP. US ENDOVASCULAR; NITINOL MANDREL 5CM RADIPPAQUE TIP (AU), ANGLED

Model Number	SGW-060-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One sample has been returned and the complaint was confirmed, galt took some pictures for returned sample shows in galt (failure investigation report).Evaluation on returned sample and from the pictures were taken at galt shows the wire has been submit to improper clinical insertion technique, the needle or other metal instrument might damage soldering area between the core and coiled wire by cutting edges of needle cannula.Some scratches appear on the surface of mandrel core wire and this might be caused by cutting edges of the needle cannula or other metal instrument.During investigation and evaluation process we found that three different subcomponent tapered core wire has been used to manufactured two lot of gwa-038-07 and then later being used for sgw-060-01, the results of ball weld tensile pull test for tapered core wire before coiling process shows below; crw-010-14 (15350749): min (1.766) lbs.And max (2.758) lbs.Crw-010-14 (15350750): min (1.172) lbs.And max (1.588) lbs.Crw-010-14 (15350752): min (1.558) lbs.And max (2.686) lbs.Minimum tensile pull force for ball weld on distal tip tapered core wire must meet or exceed (1.1) lbs.Per galt applicable procedure.From table (1) above we can see minimum tensile pull force is (1.172) lbs.And maximum pull force is (2.758) lbs.And all dhrs shows the products have been manufactured to specifications and the product is capable to handle pull force > (1.1) lbs.Root cause: root cause of this incident might be end user did not follow instructions on ifu and the wire might be twisted due to improper insertion technique.
Event or Problem Description
As received from end user through the customer (physician was in the middle of treating a popliteal lesion, through a 5-6 slender sheath.Tight and tortuous anatomy.He was using a crosser and as he pulled back to the tibia, he noticed the wire tip had separated from the wire shaft.(not sure where the separation occurred) multiple attempts were made to retrieve the wire, but he ended up trapping the tip under a sheath).

• Brand Name: US ENDOVASCULAR
• Common Device Name: NITINOL MANDREL 5CM RADIPPAQUE TIP (AU), ANGLED
• Manufacturer (Section D): GALT MEDICAL CORP.; 2220 merritt dr; garland TX 75041
• MDR Report Key: 7298088
• Report Number: 1649395-2018-00008
• Device Sequence Number: 14032016
• Product Code: DQX
• UDI-Device Identifier: 10841268100487
• UDI-Public: 10841268100487
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K021990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2018
• Report Date (Section F): 02/26/2018

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: 07/28/2020
• Device Model Number: SGW-060-01
• Device Catalogue Number: USEGS14-300A
• Device Lot Number: G16172485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/08/2018
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 02/26/2018