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

Model Number	INS-5450
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Airway Obstruction (1699); Foreign Body In Patient (2687)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During post-procedure xra, the coil from the end of the spin xtend needle was found in the patient's airway.The patient had to have an additional procedure to remove the coil.
Additional Manufacturer Narrative
This report is being supplemented to provide information that was inadvertently not included in the initial medwatch report, to correct information provided in the initial report, and to provide the results of the investigation of the reported event.Correction to b1, b2, and h1: this event is also considered to be an adverse event/serious injury due to the intervention required to remove the "coil".Correction to b4 of initial report: date of this report was 13-apr-2021.The subject device was not returned for evaluation; therefore, a definitive root cause could not be determined.However, a health hazard evaluation (hhe) was performed for the reported failure.The "coil" is a stainless steel spiral guard which is located in the distal end of the device that dislodged from the ptfe teflon sheath.The hhe determined that when the spiral guard has dislodged from the ptfe teflon sheath, it has the potential to damage surrounding tissue, resulting in harm to the patient.For this event, there was no report of patient harm or tissue damage.Although the subject device was not returned, there was an investigation performed on a returned device for a similar complaint.In that investigation, there was no visible damage to the instrument identified that could have led to the failure mode.Additionally, there was no visible damage to the spiral guard itself.The device was then actuated repeatedly to determine if the functionality of the needle was affected and no malfunction was observed.In addition, a total of five (5) ins-5450 devices were subject to a battery of tests in an attempt to recreate the failure mode.Ultimately, the exact failure mode (i.E., the spiral guard becoming dislodged) could not be replicated.Despite not being able to recreate the failure, the investigation did conclude that the receiving inspection criterial for the ins-2450 (i.E., the raw material code for the ins-5450) be revised to include an inspection step to ensure that the spiral guard is located at the specified distance from the end of the ptfe teflon sheath.This supplemental report is being submitted as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.

• Brand Name: SPIN XTEND NEEDLE
• Common Device Name: NEEDLE
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer (Section G): VERAN MEDICAL TECHNOLOGIES, INC; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer Contact: jennifer andre ; 1938 innerbelt business center; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 11655966
• Report Number: 3007222345-2021-00007
• Device Sequence Number: 12304107
• Product Code: JAK
• UDI-Device Identifier: 00815686020651
• UDI-Public: 00815686020651
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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?: 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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown