MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC ALWAYS-ON TIP TRACKED FORCEPS; BIOPSY FORCEPS

Model Number	INS-0372
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pneumothorax (2012)
Type of Reportable Event	Serious Injury
Event or Problem Description
Veran vsupport was made aware on 01-oct-2021 of a research article published in "lung." the title of the research article is: 4d electromagnetic navigation bronchoscopy for the sample of pulmonary lesions: first european real-life experience.The article mentions using the veran spin thoracic navigation system and two of the vern instruments: forceps and 21 ga needle.The article states that there was one incidence of pneumothorax while using the veran spin navigation system.No additional information was given in the article.
Additional Manufacturer Narrative
This report is directly linked to the 3007222345-2022-00015.The article referenced in the description of the event mentioned two devices used.No additional information was given in the article.
Event or Problem Description
Additional information regarding the reported event: the pneumothorax resolved spontaneously.This medwatch report was submitted for the ins-0372 always-on tip tracked forceps - serrated cup.The ins-0392 always-on tip tracked 21ga anso cytology needle was submitted on medwatch 3007222345-2022-00015.
Additional Manufacturer Narrative
This report is being supplemented to provide information that was inadvertently not included in the initial medwatch report and to provide the results of the investigation of the event.G3: date received by manufacturer was blank in the initial medwatch report and should have been 01-oct-2021.No product was returned for this investigation.The subject article was reviewed to aid in the investigation.Patrucco et al.(2021) stated the use of veran medical technologies vpad2, spin thoracic navigation system, and electromagnetic tip-tracked biopsy instruments (21 gauge needle and 1.8-mm outer diameter serrated cup always-on tip forceps).Patrucco et al.(2021) performed 103 procedures, on 77 patients, with one reported pneumothorax.The pneumothorax resolved spontaneously.No other complications were reported.No other details were given with respect to the pneumothorax.The 21 gauge needle cited in the study is most likely to be the ins-0392, always-on tip tracked 21ga anso cytology needle, 15mm l, 1.8mm od.The 1.8-mm outer diameter serrated cup always-on tip forceps cited in the study is most likely to be the ins-0372, always-on tip tracked forceps - serrated cup.Based on a review of the risk documentation, the following are identified as potential causes of hazards resulting in a pneumothorax: 1.Coil location relative to instrument tip not consistent throughout manufacturing process and not properly uniquely quantified for each unit resulting in incorrect instrument tip location reported.2.Instrument (accessory) such as stylet for sample removal is not removed prior to insertion into bronchoscope.3.User samples with device in anatomical area (across fissure or pleural wall) that is inappropriate or aggressive in location.4.Electromagnetic field for localization is disturbed by emi or large metallic object in the field resulting in incorrect instrument tip location reported.There was insufficient evidence to attribute a failure mode for this specific complaint.There was no allegation of device malfunction of any veran device.A pneumothorax is a known risk of the device and the procedure.References and link to article: patrucco, f., daverio, m., airoldi, c., falaschi, z., longo, v., gavelli, f., boldorini, r.L., & balbo, p.E.(2021).4d electromagnetic navigation bronchoscopy for the sampling of pulmonary lesions: first european real-life experience.Lung, 199(5), 493-500.Https://link.Springer.Com/article/10.1007/s00408-021-00477-z.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: ALWAYS-ON TIP TRACKED FORCEPS
• Common Device Name: BIOPSY FORCEPS
• 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: 14190220
• Report Number: 3007222345-2022-00016
• Device Sequence Number: 4474343
• Product Code: JAK
• UDI-Device Identifier: 00815686020576
• UDI-Public: 00815686020576
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other,Foreign,Literature,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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?: No
• Device Model Number: INS-0372
• Device Catalogue Number: INS-0372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SPIN THORACIC NAVIGATION SYSTEM; VPAD2
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose