MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2008-05-28 for FASCIAL DILATORS 10F (BX10) M001482501 manufactured by Boston Scientific Corporation.
[874437]
It was reported that during a rig treatment procedure, the dilator fractured on insertion. During insertion of the 10f fascial dilator, the hub separated from the shaft of the dilator leaving the dilator inside the patients abdomen, and the hub in the hands of the clinician. Enough of the dilator shaft was protruding from the patient's abdomen for the physician to grasp the dilator with his fingers and remove the device from the pt. It was reported that had enough shaft had not been present, it would have required the patients abdomen being surgically opened to remove the dilator. Another dilator was inserted to complete the procedure. There were no reported pt complications and the patient's condition post procedure was reported as stable.
Patient Sequence No: 1, Text Type: D, B5
[8016207]
The product was not returned for analysis. The fmea's were reviewed and the identified potential root cause for this potential failure mode that appears to be related is listed as inadequate hub joint strength. The identified potential root cause could be related to the failure mode of the complaint but the device was not returned, so it cannot be confirmed. A review of the device history record was performed and revealed no related issues to this complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134265-2008-01509 |
| MDR Report Key | 1053667 |
| Report Source | 01,05,06 |
| Date Received | 2008-05-28 |
| Date of Report | 2008-04-28 |
| Date of Event | 2008-04-16 |
| Date Mfgr Received | 2008-04-28 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2008-08-05 |
| 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 | 0 |
| 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 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 780 BROOKSIDE DR. |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FASCIAL DILATORS |
| Generic Name | GCC - DILATOR, CATHETER |
| Product Code | GCC |
| Date Received | 2008-05-28 |
| Model Number | 10F (BX10) |
| Catalog Number | M001482501 |
| Lot Number | 0011287728 |
| Device Expiration Date | 2010-11-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1056877 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 780 BROOKSIDE DR. SPENCER IN 47460 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-28 |