MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2001-09-07 for VENT MANDREL DSB DETACHABLE SILICONE BALLOON * 430170 manufactured by Target Therapeutics/a Division Of Boston Scientific Corporation.
[231678]
It was reported to bsc-target that during the procedure the vent mandrel fractured 1/2 way up. A second unit was used and procedure was successful. Per additional information requested through a company representative in august 2001: "the wire broke as the physician was putting it into the catheter. It broke halfway up the shaft definitely proximal to the tubing. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000078-2001-00054 |
| MDR Report Key | 351061 |
| Report Source | 07 |
| Date Received | 2001-09-07 |
| Date of Report | 2001-09-07 |
| Date of Event | 2001-08-07 |
| Date Mfgr Received | 2001-08-08 |
| Device Manufacturer Date | 2001-06-01 |
| Date Added to Maude | 2001-09-14 |
| 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 | ANITA NEUMAN |
| Manufacturer Street | 47900 BAYSIDE PARKWAY |
| Manufacturer City | FREMONT CA 945386515 |
| Manufacturer Country | US |
| Manufacturer Postal | 945386515 |
| Manufacturer Phone | 8006622415 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENT MANDREL DSB DETACHABLE SILICONE BALLOON |
| Generic Name | VENT MANDREL |
| Product Code | MZQ |
| Date Received | 2001-09-07 |
| Returned To Mfg | 2001-08-23 |
| Model Number | * |
| Catalog Number | 430170 |
| Lot Number | 4064612 |
| ID Number | * |
| Device Expiration Date | 2004-06-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 340343 |
| Manufacturer | TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 47900 BAYSIDE PARKWAY FREMONT CA 945386515 US |
| Baseline Brand Name | VENT MANDREL DSB DETACHABLE SILICONE BALLOON |
| Baseline Generic Name | VENT MANDREL |
| Baseline Model No | NA |
| Baseline Catalog No | 430170 |
| Baseline ID | NA |
| Baseline Device Family | DSB DETACHABLE SILICONE BALLOON |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K965071 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-09-07 |