MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-11-20 for MEDIKIT SUPER SHEATH N/A JS0489 manufactured by Togo Medikit Co. Ltd..
[60424757]
The returned sheath was examined and it was confirmed that the sheath was fractured at the portion located 16mm from the sheath hub. Cross-section surface of fractured sheath was examined at a magnification. A cut made with something sharp was observed on the fractured portion. Also, stretching was observed on the remaining portion of tube. The manufacturing process was reviewed and it was determined that a fracture such as that observed is not possible to occur as a result of the manufacturing process. A possible cause is that the tensile strength of sheath was decreased due to contact with a sharp object such as an introducer needle or an anesthetizing needle, and then the sheath might have fractured at point of contact when it was pulled out.
Patient Sequence No: 1, Text Type: N, H10
[60424758]
On 20 april 2015 at the (b)(6) medical center in (b)(6) it was reported that during a case a puncture developed when using the medikit supersheath catalog number js0489 with 2 pieces of the sheath (femoral approach). Initially the first sheath punctured and after that the second. When the first sheath was pulled out after the second sheath was punctured, sheath was fractured and torn. The fractured sheath tube remained in the body, and it was removed through an incision in the abdomen. There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612126-2016-99999 |
| MDR Report Key | 6115919 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-20 |
| Date of Report | 2015-09-28 |
| Date of Event | 2016-09-10 |
| Date Mfgr Received | 2015-04-28 |
| Date Added to Maude | 2016-11-20 |
| 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 | YASHASWINI PATWARDHAN |
| Manufacturer Street | 747 N.MILWAUKEE AVE SUITE 102 |
| Manufacturer City | LIBERTYVILLE IL 60048 |
| Manufacturer Country | US |
| Manufacturer Postal | 60048 |
| Manufacturer G1 | TOGO MEDIKIT CO. LTD. |
| Manufacturer Street | 17148-6 AZA KAMEKAWA OAZA HICHIYA |
| Manufacturer City | HYUGA CITY, MIYAZAKI PREFECTURE 883-0062 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 883-0062 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDIKIT SUPER SHEATH |
| Generic Name | CARDIAC CATHETER INTRODUCER KIT |
| Product Code | OFC |
| Date Received | 2016-11-20 |
| Model Number | N/A |
| Catalog Number | JS0489 |
| Lot Number | NOT KNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOGO MEDIKIT CO. LTD. |
| Manufacturer Address | 17148-6 AZA KAMEKAWA OAZA HICHIYA HYUGA CITY, MIYAZAKI PREFECTURE 883-0062 JA 883-0062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-20 |