MAUDE Adverse Event Report: GALT MEDICAL CORP ENHANCE TRANSCAROTID/PERIPHERAL ACCESS KIT; 4F TRANSITIONLESS MICRO-INTRODUCER KIT (SILK ROAD REF #: SR-4F21G7D-MP)

Model Number	SR-4F21G7D-MP
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint received by manufacturer from the customer ((b)(4)) on 3/10/2021 and manufacturer (galt medical corp) generate rma for end user in order to return subject complaint device for evaluation.A follow up report will be sent to fda once subject device returned and evaluation completed by manufacturer.
Event or Problem Description
End user sent complaint description to distributer ((b)(4)) and the distributer notified manufacturer (galt) as stated.(it was reported that during a tcar procedure, the micro-puncture sheath came apart in half when removing after tunnel.Both pieces were retrieved and no harm to patient.Silk road followed up and got the following additional information: during the procedure the physician was tunneling the sheath due to a deep carotid.Physician tunneled,.035 wire was advanced into the eca and then during the process of exchanging the micro-puncture sheath for the 8fr sheath the physician noticed resistance.She pulled steady back tension on the micro-puncture sheath and when it came out, we noticed the entire sheath was not intact.The physician then saw the rest of the sheath in the cca through her cutdown and removed the rest surgically.The rest of the tcar went well and patient is doing well).

• Brand Name: ENHANCE TRANSCAROTID/PERIPHERAL ACCESS KIT
• Common Device Name: 4F TRANSITIONLESS MICRO-INTRODUCER KIT (SILK ROAD REF #: SR-4F21G7D-MP)
• Manufacturer (Section D): GALT MEDICAL CORP; 2220 merritt dr #100; garland TX 75041
• MDR Report Key: 11497521
• Report Number: 1649395-2021-00004
• Device Sequence Number: 4881573
• Product Code: OFL
• UDI-Device Identifier: 20841268107254
• UDI-Public: 20841268107254
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/16/2021

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: 09/28/2024
• Device Model Number: SR-4F21G7D-MP
• Device Catalogue Number: KIT-075-03
• Device Lot Number: G20223051
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/16/2021
• 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