MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-02-06 for INOUE BALLOON CATHETER PTMC-26 manufactured by Toray Industries, Inc..
[177998119]
The facility discarded the inoue balloon catheter used in this patient, therefore it is impossible to investigate it anymore. We investigated the manufacturing record of the lot used in this patient and we have confirmed that there was nothing wrong in the manufacturing record. We judged that this event is not caused by manufacturing process based on the investigation of manufacturing record.
Patient Sequence No: 1, Text Type: N, H10
[177998120]
Balloon prepped as per normal. Balloon was inflated within the valve but failed to deflate. Dr pulled on syringe and it deflated a little bit. Patient went into vt so dr pulled out balloon and managed to remove from the body. The balloon was discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612812-2020-00001 |
| MDR Report Key | 9676801 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-06 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2018-11-22 |
| Date Added to Maude | 2020-02-06 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. SHUNSUKE KOBAYASHI |
| Manufacturer Street | 461 FIFTH AVENUE, 9TH FLOOR |
| Manufacturer City | NEW YORK NY 10017 |
| Manufacturer Country | US |
| Manufacturer Postal | 10017 |
| Manufacturer Phone | 2126978150 |
| Manufacturer G1 | TORAY INDUSTIES, INC. SETA PLANT |
| Manufacturer Street | 1-1, OE 1-CHOME |
| Manufacturer City | OTSU, SHIGA 520-2141 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 520-2141 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INOUE BALLOON CATHETER |
| Generic Name | CATHETER, PERCUTANEOUS (VALVULOPLASTY) |
| Product Code | MAD |
| Date Received | 2020-02-06 |
| Catalog Number | PTMC-26 |
| Lot Number | 181121 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORAY INDUSTRIES, INC. |
| Manufacturer Address | 1-1, NIHONBASHI-MUROMACHI 2-CHOME CHUO-KU, 103-8666 JA 103-8666 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2020-02-06 |