MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN XTEND

Model Number	INS-5450
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient is a (b)(6) male weighing (b)(6) with no relevant preexisting conditions.Physician made 3 passes with the spin xtend needle.Before inserting the needle into the scope on the 4th pass, physician noticed a piece of metal sticking out of the distal end, just barely passed the sheath.I came around to inspect.We deployed the needle, while outside of the patient, to test it and the metal piece remained stationary.I suggested we could replace it, but physician went forward with the same needle for a 4th pass.Physician completed his 4th pass but when he removed the needle from the scope, he noticed the metal piece was not sticking out anymore.He immediately asked for a therapeutic scope and conventional forceps, where he discovered the metal piece was inside the tracheal tube.He successfully removed it with the forceps and moved on to ebus.

• Brand Name: SPIN XTEND
• Common Device Name: SPIN XTEND
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC; 1938 innerbelt business center; saint louis MO 63114
• MDR Report Key: 10806667
• Report Number: 3007222345-2020-00013
• Device Sequence Number: 2962827
• Product Code: JAK
• UDI-Device Identifier: 00815686020651
• UDI-Public: 00815686020651
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170023
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2020

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: Health Professional
• Device Expiration Date: 03/04/2022
• Device Model Number: INS-5450
• Device Catalogue Number: INS-5450
• Device Lot Number: 03713190304
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 11/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 84