MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-04-12 for NVISIONVLE OPTICAL PROBE 94301-M-17 manufactured by Ninepoint Medical, Inc..
[141756580]
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.
Patient Sequence No: 1, Text Type: N, H10
[141756581]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008805841-2019-00001 |
| MDR Report Key | 8508898 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-11 |
| Date of Event | 2019-03-22 |
| Date Mfgr Received | 2019-03-22 |
| Device Manufacturer Date | 2018-05-15 |
| Date Added to Maude | 2019-04-12 |
| 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. 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 | 2019-04-12 |
| Model Number | 94301-M-17 |
| Catalog Number | 94301-M-17 |
| Lot Number | 005346 |
| Device Expiration Date | 2019-03-31 |
| 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. Hospitalization; 2. Required No Informationntervention | 2019-04-12 |