MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-13 for INFINITY ERCP SAMPLING DEVICE 00711652 manufactured by United States Endoscopy Group, Inc..
[183479508]
Through follow up with the user facility, us endoscopy learned that excessive force was applied in order to pass the sampling device through a hardened stricture. Statements in the instructions for use include: "when using a guide wire, hold the guidewire while brushing for cellular material. Otherwise the guidewire may move and cause patient injury. After selective cannulation of the desired duct is achieved and the guide wire is placed beyond the desired site for brushing: advance the infinity ercp sampling device over the guidewire. Observe the guidewire as it exits the hole approximately 20 cm from the tip of the catheter. If using a guidewire locking device, unlock the short guidewire per manufacturer's recommendations. Advance the device into the accessory channel of the endoscope and relock the guidewire. Using short strokes (1" - 1. 5"), continue to advance the device until the distal end of the sheath is endoscopically visualized. " the device subject of the reported event was not returned for evaluation. The device history record was reviewed and confirmed the device was manufactured to specification. There have been no other complaints associated with this lot. A us endoscopy representative has offered in-service training regarding use of the infinity ercp sampling device to the facility; however, the facility has declined. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[183479509]
The user facility reported a perforation to the common bile duct during a sampling procedure which included use of the infinity ercp sampling device. A covered stent was placed to address the perforation and the patient is reported to have fully recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2020-00008 |
| MDR Report Key | 9831987 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2018-10-29 |
| Date Added to Maude | 2020-03-13 |
| 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 | 3 |
| Brand Name | INFINITY ERCP SAMPLING DEVICE |
| Generic Name | SAMPLING DEVICE |
| Product Code | FDX |
| Date Received | 2020-03-13 |
| Model Number | 00711652 |
| Catalog Number | 00711652 |
| Lot Number | 1818265 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-13 |