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.
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