MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-03-20 for NVISIONVLE OPTICAL PROBE 95301-M-20 manufactured by Ninepoint Medical, Inc..
[102950369]
The 20 mm nvisionvle? Optical probe was returned to ninepoint medical for evaluation. Balloon fold lines were observed, suggesting it was pulled about two-thirds of its length into the endoscope. The distal one-third of the balloon was not folded but inverted. This suggests that a pillow of air was present at the tip which prevented passage of the optical probe into the endoscope. The separation of the balloon from the sheath occurs when the balloon is insufficiently evacuated prior to removal. The evidence indicates that the majority of the balloon was inside the endoscope at the time of failure and thus no internal components of the optical probe had come into contact with the patient. The device history record was reviewed and no anomalies were identified that could have contributed to this event. Related warnings and precautions in the instructions for use specify: 1) when drawing the optical probe into the endoscope, if pillowing is observed, stop and either re-inflate and deflate, or remove the optical probe and scope as a system. 2) use care when manipulating the endoscope while the balloon guide sheath is inflated. Extreme manipulations of the endoscope may result in breakage of the optical probe. 3) this device will inflate to labeled diameter and therefore, should not be used in any anatomy where this size would be inappropriate. 4) strictures, inflammatory disease or esophageal masses may prevent the adequate expansion of the optical probe.
Patient Sequence No: 1, Text Type: N, H10
[102950370]
The physician selected a 20 mm nvisionvle? Optical probe, which contains a 20 mm balloon, for the oct imaging evaluation. The optical probe was inserted through the working channel of the endoscope, inflated, and the imaging procedure was performed successfully. At the end of the imaging procedure, the technician deflated the 20 mm balloon and began to remove the optical probe. At this point, it was noted that the optical probe had difficulty being removed from the endoscope. The optical probe was removed from endoscope, however they noticed that the balloon was detached from the optical probe and lodged in the endoscope channel. The endoscope with lodged balloon was removed from patient. It was observed that the optical probe was lodged in the endoscope and the proximal end of the balloon was still partially inflated. It is presumed that the balloon was not fully deflated before trying to remove the optical probe. The optical probe's balloon was removed from the endoscope channel and the endoscope was reinserted. Upon further examination of patient after the oct imaging procedure, two bleeding mucosal tears near the esophagogastric junction were noticed. The bleeding was stopped with 2 hemostatic clips at the site. There were no strictures or hernia noticed in that area. The physician was not concerned about the bleeding, and the procedure including subsequent biopsy was completed with no complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008805841-2018-90002 |
| MDR Report Key | 7354822 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-03-20 |
| Date of Report | 2018-03-20 |
| Date of Event | 2018-02-20 |
| Date Mfgr Received | 2018-02-21 |
| Device Manufacturer Date | 2017-10-18 |
| Date Added to Maude | 2018-03-20 |
| 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 | DR. EMAN NAMATI |
| Manufacturer Street | 12 OAK PARK DRIVE |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 6172507190 |
| 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 | 2018-03-20 |
| Returned To Mfg | 2018-02-21 |
| Model Number | 95301-M-20 |
| Catalog Number | 95301-M-20 |
| Lot Number | 5263 |
| Device Expiration Date | 2018-09-30 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-03-20 |