MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-01-20 for SPYGLASS DIRECT VISUALIZATION SYSTEM M00546230 4623 manufactured by Boston Scientific - Marlborough.
[2466205]
It was reported to boston scientific corporation that an ercp (endoscopic retrograde cholangiopancreatography) procedure took place for biliary stone extraction. According to the complainant, during the procedure, a sphincterotomy and balloon dilatation were performed. Stone extraction was attempted with an extractor balloon and lithotripsy basket. While irrigating with the spyglass catheter, the physician noted that the patient's etoc level dropped significantly. After 15 minutes of attempting to use the spyglass catheter, the procedure was aborted with the stones remaining in the patient. It was reported that there were no device malfunctions during the procedure. No additional patient complications were reported at the conclusion of the procedure. According to the physician, the patient experienced a stroke approximately 2 days after the procedure. The physician stated that the cause of the stroke is unknown. He stated that he could not rule out that an air embolism led to the patient experiencing a stroke post procedure. The current condition of the patient was reported to be "fine. "
Patient Sequence No: 1, Text Type: D, B5
[9529401]
Although the patient's exact age is unknown, the patient is over 18 years of age. (b)(4). 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
[20416376]
It was reported to boston scientific corporation that an ercp (endoscopic retrograde cholangiopancreatography) procedure took place for biliary stone extraction. According to the complainant, during the procedure, a sphincterotomy and balloon dilatation were performed. Stone extraction was attempted with an extractor balloon and lithotripsy basket. While irrigating with the spyglass catheter, the physician noted that the patient's etoc level dropped significantly. After 15 minutes of attempting to use the spyglass catheter, the procedure was aborted with the stones remaining in the patient. It was reported that there were no device malfunctions during the procedure. No additional patient complications were reported at the conclusion of the procedure. According to the physician, the patient experienced a stroke approximately 2 days after the procedure. The physician stated that the cause of the stroke is unknown. He stated that he could not rule out that an air embolism led to the patient experiencing a stroke post procedure. The current condition of the patient was reported to be "fine. " updated information 06feb2012. Under fluoroscopic visualization, there was noted to be a "gas bubble" while the spyglass catheter was within the patient. The patient was described as stable post procedure.
Patient Sequence No: 1, Text Type: D, B5
[20538036]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2012-00227 |
| MDR Report Key | 2423459 |
| Report Source | 05,07 |
| Date Received | 2012-01-20 |
| Date of Report | 2011-12-30 |
| Date Mfgr Received | 2012-02-06 |
| Date Added to Maude | 2012-01-20 |
| 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. CHARLES MONTGOMERY |
| 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 | 2012-01-20 |
| Model Number | M00546230 |
| Catalog Number | 4623 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Other | 2012-01-20 |