MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-16 for ACCESSORY KIT, VISUALASE BODY 9735570 manufactured by Medtronic Navigation, Inc.
[142347482]
No parts have been received by the manufacturer for evaluation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[142347483]
Medtronic received information regarding a thermal therapy system being used for a non-neuro soft tissue ablation procedure. It was reported that intra-operatively, the cooling catheter "accordioned" when the stiffening stylet was advanced through the catheter damaging the catheter. The site had to open a new set to complete the case. There was a five minute delay to the procedure due to this issue. There was no reported impact to patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2019-01781 |
| MDR Report Key | 8519919 |
| Date Received | 2019-04-16 |
| Date of Report | 2019-04-16 |
| Date of Event | 2019-03-19 |
| Date Mfgr Received | 2019-03-19 |
| Device Manufacturer Date | 2018-05-04 |
| Date Added to Maude | 2019-04-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MEDTRONIC NAVIGATION, INC |
| Manufacturer Street | 826 COAL CREEK CIRCLE |
| Manufacturer City | LOUISVILLE CO 80027 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80027 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ACCESSORY KIT, VISUALASE BODY |
| Generic Name | CANNULA AND TROCAR, SUPRAPUBIC, NON-DISPOSABLE |
| Product Code | FBM |
| Date Received | 2019-04-16 |
| Model Number | 9735570 |
| Catalog Number | 9735570 |
| Lot Number | 2018050456 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NAVIGATION, INC |
| Manufacturer Address | 826 COAL CREEK CIRCLE LOUISVILLE CO 80027 US 80027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-16 |