MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-10 for INFINITY ERCP SAMPLING DEVICE 00711653 manufactured by United States Endoscopy Group, Inc..
[141565714]
The fluoroscopic marker is a radiopaque band situated within the guidewire lumen near the distal end of the device. The handle assembly, control cable, and catheter were discarded by the user facility. The distal portion of the device was visually examined; however, a full investigation could not be completed with the partial device. The instructions for use include the following statements: "do not force the brush through the endoscope's channel. Reduce angulation of the scope if resistance is met. Prior to the procedure, actuate the handle several times to be sure the brush functions properly. If the unit does not function properly, or there is evidence of damage (e. G. , bent brush, bent brush stem, kinked catheter), do not use this product and contact your local product specialist. When using a guidewire, irrigate the guidewire lumen of the catheter with sterile water/saline. " the device history record was reviewed and confirmed the devices were manufactured to specification. There have been no other complaints associated with this lot. A review of past complaints confirmed this event to be isolated. Us endoscopy has offered in-service training on the use of the device; however, the user facility declined. There have been no further issues reported.
Patient Sequence No: 1, Text Type: N, H10
[141565715]
Reference user facility medwatch report #5085400. The user facility reported that following a sampling procedure, the fluoroscopic marker from the infinity sampling device was detected in the biliary duct. Intervention was required to retrieve the marker.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2019-00017 |
| MDR Report Key | 8501918 |
| Date Received | 2019-04-10 |
| Date of Report | 2019-04-10 |
| Date of Event | 2019-03-12 |
| Date Mfgr Received | 2019-03-12 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2019-04-10 |
| 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 | MRS. COLETTA COHARA |
| Manufacturer Street | 5976 HEISLEY RD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403586251 |
| Manufacturer G1 | UNITED STATES ENDOSCOPY GROUP, INC. |
| Manufacturer Street | 5976 HEISLEY RD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INFINITY ERCP SAMPLING DEVICE |
| Generic Name | SAMPLING DEVICE |
| Product Code | FDX |
| Date Received | 2019-04-10 |
| Model Number | 00711653 |
| Catalog Number | 00711653 |
| Lot Number | 1809100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNITED STATES ENDOSCOPY GROUP, INC. |
| Manufacturer Address | 5976 HEISLEY RD MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-10 |