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 2018-09-26 for INOUE BALLOON CATHETER PTMC-26 manufactured by Toray Industries, Inc..
[121782027]
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
[121782028]
Left atrial appendage laceration with secondary cardiac tamponade requiring emergency surgery to correct. Valve anatomy was deemed suitable for commissurotomy but large left atrium with high degree of atrial septal deviation noted. Transseptal puncture completed at 3. 7cm height without incident. Wire introduced, septum dilated twice and device advanced over the wire. Septal crossing, and systematic advance around atrium and above mitral valve also unremarkable. Guide wire and stretching tube removed stylet introduced. Several attempts to cross mitral valve were unsuccessful, always lying over posterior aspect of valve, unable to obtain adequate angle to cross mitral valve. Wire reintroduced again and device repositioned, again multiple attempts unsuccessful. Wire reintroduced and device advanced retrograde direction over wire (the loop method) to gain better angle on mitral valve, this was also unsuccessful due to large size of atrium, device would not maintain retrograde orientation. Wire reintroduced and device advanced to mitral valve again, after several unsuccessful attempts an effusion was noted at left atrium/left ventricle area of pericardium. Case was aborted due to velocity of blood loss, patient underwent pericardiocentesis and blood transfusion, always deemed stable throughout. Inoue balloon retrieved intact prior to transport to surgery. The patient taken to main operating room for emergency surgery to correct atrial wall/possible appendage defect. The patient did not survive the surgery. There is no complaint of device problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612812-2018-00002 |
| MDR Report Key | 7911209 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-09-26 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-09-05 |
| Date Mfgr Received | 2018-09-05 |
| Device Manufacturer Date | 2018-01-24 |
| Date Added to Maude | 2018-09-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2018-09-26 |
| Catalog Number | PTMC-26 |
| Lot Number | 180123 |
| 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. Death; 2. Required No Informationntervention | 2018-09-26 |