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

Model Number INS-5450

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/19/2019

Event Type  malfunction  

Event 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
• Type of Device: SPIN XTEND 2.0MM OD, 21GA
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC; 1908 innerbelt business center; saint louis MO 63114
• Manufacturer (Section G): VERAN MEDICAL TECHNOLOGIES, INC; 1908 innerbelt business center; saint louis MO 63114
• Manufacturer Contact: christine hardin ; 1908 innerbelt business center; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 9496787
• MDR Text Key: 205678282
• Report Number: 3007222345-2019-00022
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00815686020651
• UDI-Public: 00815686020651
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1