MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-16 for NVISIONVLE OPTICAL PROBE 95101-20 manufactured by Ninepoint Medical, Inc..
[26251937]
The device was not returned to ninepoint medical, so no failure examination could be performed. Examination of the optical probe's lot device history record showed no anomalies with that lot, nor any other issues that pointed to this type of failure. The optical probe balloon is designed to be non-compliant, meaning it will achieve its labeled diameter at inflation pressure, but will not increase any more than its labeled diameter even with additional pressure applied. Each optical probe balloon diameter is inspected for diameter and length by the supplier, so the risk is remote that the balloon diameter would be "big" or greater than its labeled diameter. The product labeling does state that the device and endoscope can be removed as a system if a balloon appears to be deflating slowly or not at all. The most probable cause of the device failure is the break in the optical probe's inner optical core. This may have created a binding inside the inner lumen of the optical probe, closing off the lumen that allows for balloon inflation and deflation. This would make balloon deflation difficult, even impossible, depending on the severity of the optical core binding. Device not returned to company for eval
Patient Sequence No: 1, Text Type: N, H10
[26251938]
Patient was undergoing esophagogastroduodenoscopy (egd) with the ninepoint medical nvisionvle? Imaging system. Imaging was being conducted with a 20mm nvisionvle optical probe. The optical probe's inner optical core broke during manipulation to center the optics during the acquisition of a scout scan (a quick scan utilized during centering of the optics). The balloon on the optical probe was unable to deflate and therefore could not be removed from the endoscope working channel. The physician tried to deflate the balloon with no success. Although the device labeling states the optical probe and endoscope can be removed as a system, the physician did not want to pull out the endoscope/optical probe as a unit because of concern that balloon was too large. The physician cut the proximal optical probe shaft outside of the endoscope to allow the balloon and remaining distal end of the optical probe to be pushed into stomach. The proximal end of the optical probe was discarded. The physician then positioned the distal end of the endoscope against the inflated balloon. A sclerotherapy needle was inserted down the endoscope working channel and used to perforate the balloon to facilitate deflation. The sclerotherapy needle was exchanged through the endoscope working channel with rat-tooth grasping forceps, which were used to grab the distal end of the optical probe. The optical probe and endoscope were removed from the patient at the same time. No patient adverse effects were noted by the physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008805841-2015-00003 |
| MDR Report Key | 5082803 |
| Date Received | 2015-09-16 |
| Date of Report | 2015-08-19 |
| Date of Event | 2015-07-20 |
| Date Mfgr Received | 2015-07-20 |
| Device Manufacturer Date | 2015-04-20 |
| Date Added to Maude | 2015-09-16 |
| 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 | MR SCOTT BLOOD |
| Manufacturer Street | 12 OAK PARK DRIVE |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 6172507143 |
| 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 | 0 |
| Brand Name | NVISIONVLE OPTICAL PROBE |
| Generic Name | NVISIONVLE OPTICAL PROBE |
| Product Code | NQQ |
| Date Received | 2015-09-16 |
| Model Number | 95101-20 |
| Catalog Number | 95101-20 |
| Lot Number | 4536 |
| Device Expiration Date | 2016-02-28 |
| Operator | PHYSICIAN |
| 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 | 2015-09-16 |