MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-02-06 for NVISIONVLE OPTICAL PROBE, 20MM BALLOON 95101-20 manufactured by Ninepoint Medical Inc..
[5557409]
A patient undergoing esophagogastroduodenoscopy (egd) with the ninepoint medical nvisionvle imaging system and with the covidien barrx radiofrequency ablation (rfa) system. Imaging was completed with a 20 mm nvisionvle optical probe. The balloon on the optical probe was deflated and removed from endoscope working channel. The barrx rfa system was then introduced and removed from the endoscope working channel after the rfa was completed. While the endoscope was still in pt, the same 20 mm optical probe was reintroduced through the working channel for post rfa imaging. The optical probe's balloon was re-inflated and the pt was then re-imaged with the nvision imaging system. The team then attempted to deflate the balloon for removal from the endoscope working channel, however the balloon would not deflate. Multiple attempts to deflate the balloon were made with no results. The connections on nvision inflation accessory were checked and found to be secure. The team also attempted to deflate the balloon with a 35 ml luer-lock syringe. At this point, the physician felt that the balloon had deflated enough, and would be able to pull it through the endoscope working channel. However, when the optical probe was removed completely from endoscope channel, the balloon was not attached to optical probe. The endoscope was reintroduced into pt and the balloon was observed in esophagus. A snare was introduced through endoscope working channel and used to remove the balloon. The balloon and endoscope were removed from patient at same time. No adverse effects on pt were noted by the physician.
Patient Sequence No: 1, Text Type: D, B5
[13069181]
The investigation of the returned optical probe showed that the balloon completely detached from the optical probe's sheath and that it was still partially inflated. Four major kinks were noted along the optical probe sheath. The inner imaging lumen of the optical probe was stretched distally, while the proximal portion of the optical probe was found to be intact. The detached balloon was pressurized and it was unable to be inflated nor deflated with a touhy borst adapter and syringe. The most probable cause of the balloon separation from the optical probe was the attempt to remove it through the endoscope working channel while it was still partially inflated. The shaft of the optical probe would move freely in the endoscope working channel, but the balloon would become stuck at the working channel opening due to its partially-inflated size. Thus, causing the optical probe's sheath to become stretched and the balloon to become detached from the assembly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008805841-2015-00001 |
| MDR Report Key | 4567462 |
| Report Source | 06 |
| Date Received | 2015-02-06 |
| Date of Report | 2015-02-05 |
| Date of Event | 2014-12-14 |
| Date Mfgr Received | 2015-01-08 |
| Device Manufacturer Date | 2014-07-14 |
| Date Added to Maude | 2015-04-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR SCOTT BLOOD |
| Manufacturer Street | 1 KENDALL SQUARE SUITE B7501 |
| Manufacturer City | CAMBRIDGE MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal | 02139 |
| Manufacturer Phone | 6172507190 |
| Manufacturer G1 | NINEPOINT MEDICAL INC. |
| Manufacturer Street | 1 KENDALL SQUARE SUITE B7501 |
| Manufacturer City | CAMBRIDGE MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02139 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NVISIONVLE OPTICAL PROBE, 20MM BALLOON |
| Generic Name | NVISIONVLE IMAGING SYSTEM, |
| Product Code | NQQ |
| Date Received | 2015-02-06 |
| Returned To Mfg | 2015-01-12 |
| Model Number | 95101-20 |
| Catalog Number | 95101-20 |
| Lot Number | 004407 |
| Device Expiration Date | 2015-07-30 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NINEPOINT MEDICAL INC. |
| Manufacturer Address | 1 KENDALL SQUARE SUTIE B5701 CAMBRIDGE MA 02139 US 02139 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-06 |