MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-06-05 for DRAGONFLY? OPTIS? CATHETER C408641 manufactured by St. Jude Medical.
[110592035]
The dragonfly optis catheter broke at the tip while inside the patient. When the device was removed, the tip was also removed. No other tools were used. Another dragonfly optis catheter was used to complete the procedure. Patient's information (e. G. Age, weight, gender, patient's initials) cannot be handled by abbott in absence of patient's written consent as required by the personal data protection national legislation. National legislation prevents the recording of such information. A written consent has not been obtained in this case; therefore, this information is not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009600098-2018-00012 |
| MDR Report Key | 7570961 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-06-05 |
| Date of Report | 2018-07-24 |
| Date of Event | 2018-05-09 |
| Date Mfgr Received | 2018-06-18 |
| Device Manufacturer Date | 2018-01-05 |
| Date Added to Maude | 2018-06-05 |
| 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 | DENISE JOHNSON |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517564470 |
| Manufacturer G1 | ST. JUDE MEDICAL |
| Manufacturer Street | 4 ROBBINS DRIVE |
| Manufacturer City | WESTFORD MA 01886 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01886 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAGONFLY? OPTIS? CATHETER |
| Generic Name | DFII KITBOX OUS (NO SYRINGE) |
| Product Code | ORD |
| Date Received | 2018-06-05 |
| Model Number | C408641 |
| Catalog Number | C408641 |
| Lot Number | 6258957 |
| ID Number | 00183739000951 |
| Device Expiration Date | 2020-01-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | 4 ROBBINS DRIVE WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-05 |