MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-05-10 for SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE N/A THSCF-35-180-1.5-ROSEN manufactured by Cook Inc.
[144664244]
Concomitant medical products mpis-401-10. 0-sc-nt-sst; cxi-4. 0-35-90-p-ns-0; cmw-14-300-12g; mpis-401-pedal-nt-u-sst; jcd5. 0-35-20; pwa-35-260. Occupation: unknown. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[144664245]
It was reported a safe-t-j rosen catheter exchange wire guide was used in an unknown patient for an angioplasty on (b)(6) 2019. The user reports,? A patient came back in with sepsis?. The infection was identified as streptococcus agalactiae group b, requiring treatment with antibiotics. As reported, there were several other cook devices used in the initial procedure and are captured under the following report reference numbers: 1820334-2019-01171, 1820334-2019-01172 (this report), 1820334-2019-01173, 1820334-2019-01174, 1820334-2019,01175, 1820334-2019-01176, 1820334-2019-01177. No other adverse effects were reported for this incident. Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01172 |
| MDR Report Key | 8598099 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-05-10 |
| Date of Report | 2019-07-03 |
| Date of Event | 2019-04-25 |
| Date Mfgr Received | 2019-07-03 |
| Device Manufacturer Date | 2019-03-14 |
| Date Added to Maude | 2019-05-10 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE |
| Generic Name | DQX WIRE, GUIDE, CATHETER |
| Product Code | DXQ |
| Date Received | 2019-05-10 |
| Model Number | N/A |
| Catalog Number | THSCF-35-180-1.5-ROSEN |
| Lot Number | 9554026 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-05-10 |