MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06,07 report with the FDA on 2000-05-25 for INOUE BALLOON CATHETER PTMC-26 manufactured by Toray Industries, Inc./seta Plant.
[21709252]
According to initial reporter's statement, the pt underwent successful "ptmc" on april 26, 2000. A "ptmc"-26 inoue balloon catheter was used with serial inflations at 22, 23 and 23. 5mm diameter. Upon attempted withdrawal of the slenderized balloon from the left atrium a kink at the distal radiopaque tip was noted making withdrawal of the 0. 025 guidewire difficult. With fairly vigorous withdrawal the distal approx. 10cm of wire fractured and was left in the left atrium. This required repeat transseptal puncture from the left femoral vein and the wire fragment was snared into a mullins sheath and removed from the pt. There were no other complications and the pt did well post procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614758-2000-00003 |
| MDR Report Key | 279539 |
| Report Source | 00,05,06,07 |
| Date Received | 2000-05-25 |
| Date of Report | 2000-04-29 |
| Date of Event | 2000-04-26 |
| Date Mfgr Received | 2000-04-29 |
| Device Manufacturer Date | 1999-06-01 |
| Date Added to Maude | 2000-05-31 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | HIDEHIKO OKUBO, DIRECTOR |
| Manufacturer Street | 600 THIRD AVE |
| Manufacturer City | NEW YORK NY 10016 |
| Manufacturer Country | US |
| Manufacturer Postal | 10016 |
| Manufacturer Phone | 2126978150 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INOUE BALLOON CATHETER |
| Generic Name | BALLOON VALVULOPLASTY CATHETER |
| Product Code | MAD |
| Date Received | 2000-05-25 |
| Returned To Mfg | 2000-05-23 |
| Model Number | PTMC-26 |
| Catalog Number | PTMC-26 |
| Lot Number | JUNE 17 1999 |
| ID Number | * |
| Device Expiration Date | 2000-06-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 270539 |
| Manufacturer | TORAY INDUSTRIES, INC./SETA PLANT |
| Manufacturer Address | 1-1, OE 1-CHOME OTSU-SHI, SHIGA JA 520-2141 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-05-25 |