MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-01-30 for CLEARGUARD HD ANTIMICROBIAL BARRIER CAP CGHD CGHD-100 manufactured by Pursuit Vascular, Inc..
[135205642]
Actual device involved with this report was not returned for testing. The following were reviewed as part of this investigation: patient risk, frequency analysis, labelling, and applicable manufacturing records and the lots in question were manufactured per specification without deviation. Pursuit vascular was unable to replicate the reported issue despite testing same lots with an axial force of 16 lb-f applied which exceeds clinically recommended use. There was no patient injury reported with this event.
Patient Sequence No: 1, Text Type: N, H10
[135205643]
Md alleged that "stick with cha broke off into catheter. " date of event and hospital location were not provided. This event was not previously reported. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011277191-2018-00003 |
| MDR Report Key | 8289128 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-30 |
| Date of Report | 2018-12-19 |
| Date Mfgr Received | 2018-11-19 |
| Date Added to Maude | 2019-01-30 |
| 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. JAYSON BABLER |
| Manufacturer Street | 6901 EAST FISH LAKE ROAD SUITE 166 |
| Manufacturer City | MAPLE GROVE MN 553695456 |
| Manufacturer Country | US |
| Manufacturer Postal | 553695456 |
| Manufacturer Phone | 7633344284 |
| Manufacturer G1 | PURSUIT VASCULAR, INC. |
| Manufacturer Street | 6901 EAST FISH LAKE ROAD SUITE 166 |
| Manufacturer City | MAPLE GROVE MN 553695456 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 553695456 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEARGUARD HD ANTIMICROBIAL BARRIER CAP |
| Generic Name | CLEARGUARD HD |
| Product Code | PEH |
| Date Received | 2019-01-30 |
| Model Number | CGHD |
| Catalog Number | CGHD-100 |
| Lot Number | 5127, 5201, OR 5261 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PURSUIT VASCULAR, INC. |
| Manufacturer Address | 6901 EAST FISH LAKE ROAD SUITE 166 MAPLE GROVE MN 553695456 US 553695456 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-30 |