MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-28 for SPYGLASS DIRECT VISUALIZATION SYSTEM M00546230 4623 manufactured by Boston Scientific - Marlborough.
[37242195]
Visual examination of the spyscope device appeared to be in good condition with no obvious visual deformities. Functionally, a spyglass was inserted into the optic channel and it met resistance just outside the handle and it would not pass. Upon deconstruction of the device, it was noticed that there was a clear material about 4mm in length blocking the channel. Based on the product analysis, it could not be determined if this? Clear material? Was material used during the manufacturing process or foreign material of unknown origin. Therefore, the most probable root cause for this complaint is undeterminable. A dhr (device history record) review was performed and no deviation was found.
Patient Sequence No: 1, Text Type: N, H10
[37242196]
It was reported to boston scientific corporation that a spyscope access & delivery catheter was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed on (b)(6) 2015. According to the complainant, during preparation, as they were trying to pass the spyglass probe through the spyscope, it was noticed that the spyglass probe would not pass as if there was something like a "piece of plastic" blocking the scope. Reportedly, there was no visible damage noted on the spyscope access & delivery catheter. The procedure was completed with a second spyscope access & delivery catheter with the same original spyglass probe. 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. This event has been deemed reportable based on the investigation results: the evaluation of the device revealed a foreign material of unknown origin. See report for full device investigation results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2016-00162 |
| MDR Report Key | 5396426 |
| Date Received | 2016-01-28 |
| Date of Report | 2016-01-04 |
| Date of Event | 2015-09-17 |
| Date Mfgr Received | 2016-01-04 |
| Device Manufacturer Date | 2015-06-04 |
| Date Added to Maude | 2016-01-28 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMP. NANCY CUTINO |
| 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 | 0 |
| Brand Name | SPYGLASS DIRECT VISUALIZATION SYSTEM |
| Generic Name | MINI ENDOSCOPE, GASTROENTEROLOGY-UROLOGY |
| Product Code | ODF |
| Date Received | 2016-01-28 |
| Returned To Mfg | 2015-10-07 |
| Model Number | M00546230 |
| Catalog Number | 4623 |
| Lot Number | ML00002987 |
| Device Expiration Date | 2016-05-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-01-28 |