MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-24 for NVISIONVLE OPTICAL PROBE 95301-M-20 manufactured by Ninepoint Medical, Inc..
[142870576]
The reporter did indicate that the device did not malfunction during the procedure. According to the physician, the issue is believed to have been caused by dilation of an existing stricture by the optical probe balloon, which is a typical response for a stricture when in contact with any balloon. 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: 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 nvision vle optical probe.
Patient Sequence No: 1, Text Type: N, H10
[142870577]
The physician selected a 20 mm nvisionvle optical probe, which contains a 20 mm balloon, for oct imaging. The physician successfully performed the procedure. There were no nvisionvle optical probe or imaging console failures observed. When the balloon was deflated and removed from the patient, bleeding was noted and a mucosal tear was found at the site of a prior stricture. The physician then used an endoscopic clip to stop the bleeding and there was no additional follow-up or elongation of procedure. According to the physician, the stricture was dilated by the optical probe balloon, which is a typical response for a stricture when in contact with any balloon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008805841-2019-00002 |
| MDR Report Key | 8543497 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-04-08 |
| Date Mfgr Received | 2019-04-08 |
| Date Added to Maude | 2019-04-24 |
| 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 | MRS. INGA MASS |
| Manufacturer Street | 12 OAK PARK DRIVE |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 6174752322 |
| 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 | 2019-04-24 |
| Model Number | 95301-M-20 |
| Catalog Number | 95301-M-20 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-04-24 |