MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2006-12-12 for IMAGER II 31-424 manufactured by Boston Scientific Corp..
[15695331]
It was reported that prior to a carotid artery angiography diagnostic procedure, the package seal was compromised. The customer reported that, "when the nurse came to open the sterile pack on this imager catheter, she found a gap in the seal, which therefore compromised the sterility of the product. Another catheter was used instead. " the device had no contact with the patient. The procedure was successfully completed with another of the same device.
Patient Sequence No: 1, Text Type: D, B5
[15837383]
The device has not been received for analysis as of the date of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000093-2006-02586 |
| MDR Report Key | 796780 |
| Report Source | 01,05,07 |
| Date Received | 2006-12-12 |
| Date of Report | 2006-11-13 |
| Date of Event | 2006-11-08 |
| Date Mfgr Received | 2006-11-13 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2006-12-22 |
| 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 | MARK GAYLE-MS A210 |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 553111566 |
| Manufacturer Country | US |
| Manufacturer Postal | 553111566 |
| Manufacturer Phone | 7632550529 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMAGER II |
| Generic Name | DQC, CATHETER, INTRAVASCULAR, DIAGNOSTIC |
| Product Code | DQC |
| Date Received | 2006-12-12 |
| Model Number | NA |
| Catalog Number | 31-424 |
| Lot Number | 0000039891 |
| ID Number | * |
| Device Expiration Date | 2007-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 784331 |
| Manufacturer | BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | * MAPLE GROVE MN * US |
| Baseline Brand Name | IMAGER II |
| Baseline Generic Name | DQC CATHETER, INTRAVASCULAR, DIAGNOSTIC |
| Baseline Model No | NA |
| Baseline Catalog No | 31-424 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-12-12 |