MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN XTEND 2.0MM OD, 21GA

Model Number	INS-5450
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
After taking multiple biopsies with the spin xtend needle it appeared that a part of the spin xtend needle broke off, and was lying in the patient's airway.The doctor immediately pulled the spin xtend needle out of the bronchoscope, and easily retrieved the piece lying inside the patients airway.After the piece was out of the patient, the doctor decided that we had sufficient tissue, and ended the case.Upon further investigation of the instrument, it seemed that the piece surrounding the needle inside the sheath was somehow dislodged and ended up in the patient.The representative immediately packaged the instrument, and the broken piece so it can be shipped back to the office for further inspection.After speaking with the doctor, he said the patient was doing fine, and that there was abnormal issues surrounding the procedure.

• Brand Name: SPIN XTEND 2.0MM OD, 21GA
• Common Device Name: SPIN XTEND 2.0MM OD, 21GA
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC; 1908 innerbelt business center; saint louis MO 63114
• MDR Report Key: 9496787
• Report Number: 3007222345-2019-00022
• Device Sequence Number: 1877267
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2019

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: 04/22/2022
• Device Model Number: INS-5450
• Device Catalogue Number: INS-5450
• Device Lot Number: 03713190304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1