MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-08-11 for SPYGLASS DIRECT VISUALIZATION PROBE M00546030 4603 manufactured by Boston Scientific Corporation.
[18495295]
Note: this report pertains to one of two complaints that occurred during the same procedure. Refer to manufacturer report # 3005099803-2009-03810 for the other associated device information. It was reported to boston scientific corporation that a spyscope access and delivery catheter and a spyglass direct visualization probe were used during an ercp (endoscopic retrograde cholangiopancreatography) with electrohydraulic lithotripsy (ehl) procedure performed in 2009. According to the complainant, difficulty was encountered while advancing the spyprobe through the spyscope. The spyprobe appeared to become stuck at the spyscope tip. The spyscope was removed from the patient, but the spyprobe still could not be advanced through the channel. The procedure was not completed due to this event. However, a biliary stent was placed to allow duct drainage until the procedure could be re-scheduled. 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
[18684700]
The complainant was unable to provide the suspect device serial number; therefore, the device manufacture date is unknown. The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2009-03811 |
| MDR Report Key | 1436712 |
| Report Source | 05,07 |
| Date Received | 2009-08-11 |
| Date of Report | 2009-07-13 |
| Date of Event | 2009-07-09 |
| Date Mfgr Received | 2009-07-13 |
| Date Added to Maude | 2009-08-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLES MONTGOMERY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836132 |
| Manufacturer G1 | MYRIAD FIBER IMAGING TECHNOLOGIES INC. |
| Manufacturer Street | 56 SOUTHBRIDGE ROAD |
| Manufacturer City | DUDLEY MA 01571 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01571 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPYGLASS DIRECT VISUALIZATION PROBE |
| Product Code | ODF |
| Date Received | 2009-08-11 |
| Model Number | M00546030 |
| Catalog Number | 4603 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-08-11 |