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

Model Number 95101-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 02/29/2016

Event Type  Injury  

Manufacturer Narrative

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.The reporter did indicate that the device did not malfunction during the procedure, and the physician indicated that it was unavoidable, since any balloon would have likely caused a small mucosal tear with the condition of the patients' esophagus (strictured) after a circumferential emr.Related warnings in the instructions for use specify: this device will inflate to labeled diameter and therefore should not be used in any anatomy where this size would be inappropriate.Strictures, inflammatory disease or esophageal masses may prevent the adequate expansion of the nvisionvle optical probe.

Event Description

The patient was having a 3-month follow up after a circumferential endoscopic mucosal resection (emr) to treat high grade dysplasia.The patient had an esophageal stricture, which is a common complication following circumferential emr.The physician decided on a vle procedure and selected 20mm nvisionvle optical probe, which contains a 20 mm balloon, for the oct imaging evaluation.The optical probe was advanced, inflated, and the oct scan took place.After obtaining the scans and evaluating the imaging, a small mucosal tear was noticed within the imaging.After the optical probe's balloon was deflated and removed, the physician used hemostatic clips to address the small mucosal tear.The physician did not express concern, and later stated that it was unavoidable, since any balloon would have likely caused a small mucosal tear with the condition of the esophagus (strictured) after a circumferential emr.After the physician deployed the hemostatic clips, he finished the case in a normal manner by taking a targeted biopsy.

• Brand Name: NVISIONVLE OPTICAL PROBE
• Type of Device: NVISIONVLE OPTICAL PROBE
• Manufacturer (Section D): NINEPOINT MEDICAL, INC.; 12 oak park drive; bedford MA 01730
• Manufacturer (Section G): NINEPOINT MEDICAL, INC.; 12 oak park drive; bedford MA 01730
• Manufacturer Contact: heather reed ; 12 oak park drive; bedford, MA 01730 ; 6172507141
• MDR Report Key: 5520775
• MDR Text Key: 40990549
• Report Number: 3008805841-2016-00001
• Device Sequence Number: 1
• Product Code: NQQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2016
• Device Model Number: 95101-20
• Device Catalogue Number: 95101-20
• Device Lot Number: 4705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2015
• 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
• Treatment: ENDOSCOPE ( NO MFGR SPECIFIED)
• Patient Outcome(s): Required Intervention