MAUDE Adverse Event Report: NINEPOINT MEDICAL, INC. NVISIONVLE OPTICAL PROBE

Model Number	94301-M-17
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reporter did indicate that the device did not malfunction during the procedure.According to the physician, the issue is believed to have been either inflating the optical probe balloon within a stricture causing a mechanical tear or the patient excessive coughing while the optical probe balloon was inflated.Because the nvisionvle optical probe was not returned it could not be physically inspected.The device history record was reviewed and no anomalies were identified that could have contributed to this event.Related warnings in the instructions for use specify: 1) this device will inflate to labeled diameter and therefore, should not be used in any anatomy where this size would be inappropriate.2) strictures, inflammatory disease or esophageal masses may prevent the adequate expansion of the nvision vle optical probe.
Event or Problem Description
The physician selected a 17 mm nvisionvle optical probe, which contains a 17 mm balloon, for oct imaging.Optical probe balloon was inflated to 5psi to evaluate evidence of strictures, which were noted to be absent.The balloon was then inflated to 15 psi.During the vle procedure, it was noticed that the patient had a proximal esophageal wall tear.Upon this observation, the vle procedure was ended and the optical probe balloon was deflated.Patient was further inspected and the observed tear in the esophageal wall was determined to be most likely a perforation.Perforation closure was achieved with endoscopic clips.Patient was admitted for overnight observation on the day of procedure ((b)(6) 2019).The following day ((b)(6) 2019), performing physician reviewed the esophagram, reporting that the esophagram showed that the tear was closed.

• Brand Name: NVISIONVLE OPTICAL PROBE
• Common Device Name: NVISIONVLE OPTICAL PROBE
• Manufacturer (Section D): NINEPOINT MEDICAL, INC.; 12 oak park drive; bedford MA 01730
• MDR Report Key: 8508898
• Report Number: 3008805841-2019-00001
• Device Sequence Number: 1921410
• Product Code: NQQ
• UDI-Device Identifier: 00859591006065
• UDI-Public: (01)00859591006065(17)190331(10)005346
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K182616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2019

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
• Operator of Device: Other
• Device Expiration Date: 03/31/2019
• Device Model Number: 94301-M-17
• Device Catalogue Number: 94301-M-17
• Device Lot Number: 005346
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention