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 2018-05-01 for INOUE BALLOON CATHETER PTMC-26 manufactured by Toray Industries, Inc..
[106975279]
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. Instructions for use have already mentioned about this event. Considering the above, we have judged that it is not necessary to take any corrective actions.
Patient Sequence No: 1, Text Type: N, H10
[106975280]
The doctor inflated the balloon 3 times, injection volume was 22/23/23/ ml respectively. On the second inflation there was mild mitral regurgitation. During the third inflation the balloon fully expanded. Checked for mitral regurgitation and it was wide open with the a2 leaflet flailing due to a ruptured cordae. This patient received an intra aortic balloon pump to decrease the left ventricular pressure and demand. It was decided by doctors to wait until the next day for the valve replacement. The patient had already received 4 hours of anesthesia. The procedure of valve replacement was successful and patient is doing well. It was not a balloon issue. The patient measured for a 26 mm balloon. She is 152 cm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612812-2018-00001 |
| MDR Report Key | 7475418 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-05-01 |
| Date of Report | 2018-05-01 |
| Date of Event | 2018-04-03 |
| Date Mfgr Received | 2018-04-03 |
| Device Manufacturer Date | 2017-07-25 |
| Date Added to Maude | 2018-05-01 |
| 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. 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 INDUSTRIES, 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 | 2018-05-01 |
| Catalog Number | PTMC-26 |
| Lot Number | 170724 |
| Device Expiration Date | 2019-07-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORAY INDUSTRIES, INC. |
| Manufacturer Address | 1-1, NIHONBASHI-MUROMACHI 2-CHOME CHUO-KU, TOKYO 103-8666 JA 103-8666 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2018-05-01 |