MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-30 for APTUS ENDOSYSTEMS 7F TOURGUIDE STEERABLE SHEATH TG0705509 manufactured by Oscor Inc..
[185953933]
Conclusion not yet available, evaluation in process. A follow-up report will be submitted as soon as the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[185953934]
During a fevar procedure the tourguide sheath used was being pulled from the patient out of a larger 20 french sheath when the tip of the tourguide sheath broke off. There was a little resistance bringing it out before it broke but nothing too abnormal. The customer spoke with the hcp and the cause of the event cannot be determined. The tip of the sheath close to the radiopaque marker was broken off completely from the rest of the sheath. The physician used a 4 mm pta balloon to trap it and pull it out of the 20 french cook sheath that was in place. The doctor stated he was doing a planned fevar (fenestrated evar repair) on the patient and uses tour guide to cannulate the visceral vessels and placed his stents in the renal arteries. He stated that the wire was still in and the broken off piece was still on the wire. He blew up the balloon inside of the broken tip and was able to use the balloon to get the tip of the patient and through the 20 fr sheath. The patient had no complications from the broken tip of the sheath.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035166-2020-00024 |
| MDR Report Key | 9901110 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2019-12-27 |
| Date Added to Maude | 2020-03-30 |
| 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. DOUG MYERS |
| Manufacturer Street | 3816 DESOTO BLVD. |
| Manufacturer City | PALM HARBOR, FL |
| Manufacturer Country | US |
| Manufacturer Phone | 9372511 |
| Manufacturer G1 | OSCOR INC. |
| Manufacturer Street | 3816 DESOTO BLVD. |
| Manufacturer City | PALM HARBOR, FL |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APTUS ENDOSYSTEMS 7F TOURGUIDE STEERABLE SHEATH |
| Generic Name | INTRODUCER, CATHETER, PRODUCT CODE: DYB |
| Product Code | DYB |
| Date Received | 2020-03-30 |
| Model Number | TG0705509 |
| Catalog Number | TG0705509 |
| Lot Number | C8-18809 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSCOR INC. |
| Manufacturer Address | 3816 DESOTO BLVD. PALM HARBOR, FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |