MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-04-21 for NVISION VLE OPTICAL PROBE 95101-20 manufactured by Ninepoint Medical Inc..
[20146509]
The 20mm optical probe used in this procedure yielded 4 scout scans and a full scan. The nurse was asked by the physician to deflate the balloon after the final full scan. The nurse used this opportunity to train another nurse on the usage of the inflation accessory. As this instruction progressed, it was noted that the physician was attempting to remove the optical probe from the endoscope at which time where the optical probe broke. The physician looked at the white light endoscope image and observed the balloon had separated from the optical probe and was still in the pt's stomach. This was verified by ninepoint medical personnel observing the procedure by hearing the physician acknowledge that "the balloon is still in there". The damaged optical probe was removed from the endoscope, followed by the physician using a snare to secure the balloon and remove it without incident or injury to the pt. The physician noted that the detached balloon still appeared to be at least partially-inflated when he approached it with the snare, but was able to deflate it with the snare prior to removal. The pt condition was later confirmed by the physician as "ok".
Patient Sequence No: 1, Text Type: D, B5
[20527469]
The returned optical probe was analyzed as part of this complaint investigation. The optical probe was returned to ninepoint medical with the balloon detached. The proximal end of the optical probe appeared to be fine with no kinks or other damage noted. The detached balloon was prolapsed over the distal transition zone. The balloon appeared to be stretched from the proximal end towards the distal end of the balloon. The balloon was noted to be somewhat inflated, but at a lower pressure than full expansion pressure (approx 15 psi), as noted by the wrinkling on the sides and cones of the balloon. There was a tensile bond failure of the inner and outer lumen at the junction of the soft proximal balloon bond segment. The inner lumen was stretched over the torque coil, which may have resulted in air being trapped in the balloon after the balloon was damaged and was detached from the optical probe. The damage to the optical probe is indicative of attempting to remove a partially- or fully-inflated balloon through the 2. 8mm working channel of an endoscope, where the balloon will not fit through the channel and greater tension is applied by the physician, resulting in a tensile failure in the balloon sheath subassembly. This tensile failure allowed the balloon to separate from the optical probe. It is believed that the optical probe was attempted to be removed from the endoscope while the balloon was still fully- or partially-inflated, causing the optical probe sheath to become stretched and the balloon to become detached from the remainder of the optical probe.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008805841-2015-00002 |
| MDR Report Key | 4778850 |
| Report Source | 05,07 |
| Date Received | 2015-04-21 |
| Date of Report | 2015-04-21 |
| Date of Event | 2015-03-25 |
| Date Mfgr Received | 2015-03-25 |
| Device Manufacturer Date | 2014-11-05 |
| Date Added to Maude | 2015-05-19 |
| 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 | 12 OAK PARK DR |
| Manufacturer City | BEDFORD MA 017301443 |
| Manufacturer Country | US |
| Manufacturer Postal | 017301443 |
| Manufacturer Phone | 6172507190 |
| Manufacturer G1 | NINEPOINT MEDICAL INC. |
| Manufacturer Street | 12 OAK PARK DR |
| Manufacturer City | BEDFORD MA 01730144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01730 1443 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NVISION VLE OPTICAL PROBE |
| Generic Name | OPTICAL PROBE |
| Product Code | NQQ |
| Date Received | 2015-04-21 |
| Returned To Mfg | 2015-03-27 |
| Model Number | 95101-20 |
| Catalog Number | 95101-20 |
| Lot Number | 004466 |
| ID Number | NA |
| Device Expiration Date | 2015-10-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 12 OAK PARK DR BEDFORD MA 01730144 US 01730 1443 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-21 |