MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-07-24 for SPYGLASS DIRECT VISUALIZATION SYSTEM M00546230 4623 manufactured by Boston Scientific - Marlborough.
[19730756]
Note: this report pertains to one of two devices used during the same procedure. Manufacturer reports # 3005099803-2013-07518 and 3005099803-2013-07519 address these devices. It was reported to boston scientific corporation that a spyscope access & delivery catheter and spyglass direct visualization probe were used during an ercp (endoscopic retrograde cholangiopancreatography) with stone extraction procedure performed on (b)(6) 2013. According to the complainant, the patient had a large stone at the distal duct with a diverticulum at the ampulla. The physician cannulated through the common bile duct (cbd) with the spyscope delivery catheter and located the stone. The physician inserted the spyglass visualization probe and a holmium laser through the spyscope delivery catheter at the distal duct. While trying to get a good visualization of the stone, the physician perforated the duodenal diverticulum. It is unknown which device caused the perforation, however, according to the physician the patient? S anatomy may have contributed to the event. Upon fluoroscopy air was seen and the physician performed a sphincteroplasty. The stone was extracted using a retrieval balloon and an advanix stent was placed. A nasogastric tube was secured on the patient and the patient was kept overnight for monitoring. The patient's condition was reported as being fine.
Patient Sequence No: 1, Text Type: D, B5
[19796671]
The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown. However, the complainant stated that the device was used prior to the expiration date. Although the patient? S exact weight is unknown, it was reported she is over (b)(6). According to the complainant, the suspect device is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2013-07518 |
| MDR Report Key | 3245816 |
| Report Source | 05,07 |
| Date Received | 2013-07-24 |
| Date of Report | 2013-07-01 |
| Date of Event | 2013-07-01 |
| Date Mfgr Received | 2013-07-01 |
| Date Added to Maude | 2013-07-24 |
| 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 | 2013-07-24 |
| Model Number | M00546230 |
| Catalog Number | 4623 |
| 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 | 1. Required No Informationntervention | 2013-07-24 |