MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2006-08-10 for INFLATION DEVICES * 5320 manufactured by Boston Scientific.
[509408]
The complainant reported that the inflation device was being inflated and could not inflate to the prescribed pressue. The procedure was completed with a good result, but with a noticeable mucofal tear. No leak was noticed, confirmed by injection of contrast and screening. The patient expired the next day on the ward with an ophageal perforation.
Patient Sequence No: 1, Text Type: D, B5
[7838001]
This device has been received by this manufacturer, but an evaluation has not yet been performed. Therefore, a failure analysis is not available and we are unable to determine if the device met its specifications. Should further relevant details become available; a supplemental medwatch report will be filed under the appropriate sequence number. We are unable to determine the relationship between this device and the cause for this event at this time. Our directions for use outline appropriate placement, access and maintenance procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000143-2006-00001 |
| MDR Report Key | 746655 |
| Report Source | 05,06,07 |
| Date Received | 2006-08-10 |
| Date of Event | 2006-07-20 |
| Date Added to Maude | 2006-08-14 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KEN HIRAKAWA |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE |
| Manufacturer City | NATICK MA 01760 |
| Manufacturer Country | US |
| Manufacturer Postal | 01760 |
| Manufacturer Phone | 5086836264 |
| Manufacturer G1 | BOSTON SCIENTIFIC |
| Manufacturer Street | 500 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFLATION DEVICES |
| Generic Name | ACHALASIA PNEUMATIC HAND PUMP |
| Product Code | KNR |
| Date Received | 2006-08-10 |
| Model Number | * |
| Catalog Number | 5320 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 734454 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | 500 GLENS FALLS TECHNICAL PARK GLENS FALLS NY 12801 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2006-08-10 |