MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-03-23 for NVISIONVLE OPTICAL PROBE 95101-20 manufactured by Ninepoint Medical, Inc..
[40990549]
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.
Patient Sequence No: 1, Text Type: N, H10
[40990550]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008805841-2016-00001 |
| MDR Report Key | 5520775 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-03-23 |
| Date of Report | 2016-03-23 |
| Date of Event | 2016-02-29 |
| Date Mfgr Received | 2016-02-29 |
| Device Manufacturer Date | 2015-12-07 |
| Date Added to Maude | 2016-03-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. HEATHER REED |
| Manufacturer Street | 12 OAK PARK DRIVE |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 6172507141 |
| Manufacturer G1 | NINEPOINT MEDICAL, INC. |
| Manufacturer Street | 12 OAK PARK DRIVE |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01730 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NVISIONVLE OPTICAL PROBE |
| Generic Name | NVISIONVLE OPTICAL PROBE |
| Product Code | NQQ |
| Date Received | 2016-03-23 |
| Model Number | 95101-20 |
| Catalog Number | 95101-20 |
| Lot Number | 4705 |
| Device Expiration Date | 2016-10-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NINEPOINT MEDICAL, INC. |
| Manufacturer Address | 12 OAK PARK DRIVE BEDFORD MA 01730 US 01730 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-23 |