MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-06-16 for SPYGLASS DIRECT VISUALIZATION SYSTEM M00546230 4623 manufactured by Boston Scientific - Marlborough.
[4461867]
It was reported to boston scientific corporation that a spyscope access & delivery catheter was to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure. According to the complainant, during preparation, the packaging was noticed to be partially opened. Additionally, it was the internal packaging seal that was found to be intact but loose. The procedure was completed with another with the same device. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
[12002632]
The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2014-02236 |
| MDR Report Key | 3874584 |
| Report Source | 05,07 |
| Date Received | 2014-06-16 |
| Date of Report | 2014-05-30 |
| Date of Event | 2014-05-29 |
| Date Mfgr Received | 2014-05-30 |
| Device Manufacturer Date | 2013-10-22 |
| Date Added to Maude | 2014-06-16 |
| 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 | EMP. INGRID MATTE |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | MEDVENTURE TECHNOLOGY CORPORATION |
| Manufacturer Street | 2301 CENTENNIAL BOULEVARD |
| Manufacturer City | JEFFERSONVILLE IN 47130 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPYGLASS DIRECT VISUALIZATION SYSTEM |
| Generic Name | MINI ENDOSCOPE, GASTROENTEROLOGY-UROLOGY |
| Product Code | ODF |
| Date Received | 2014-06-16 |
| Model Number | M00546230 |
| Catalog Number | 4623 |
| Lot Number | ML00001804 |
| Device Expiration Date | 2014-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-16 |