SPYGLASS DIRECT VISUALIZATION SYSTEM M00546230 4623

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number3005099803-2013-07518
MDR Report Key3245816
Report Source05,07
Date Received2013-07-24
Date of Report2013-07-01
Date of Event2013-07-01
Date Mfgr Received2013-07-01
Date Added to Maude2013-07-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactEMP. INGRID MATTE
Manufacturer Street100 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834000
Manufacturer G1MEDVENTURE TECHNOLOGY CORPORATION
Manufacturer Street2301 CENTENNIAL BOULEVARD
Manufacturer CityJEFFERSONVILLE IN 47130
Manufacturer CountryUS
Manufacturer Postal Code47130
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPYGLASS DIRECT VISUALIZATION SYSTEM
Generic NameMINI ENDOSCOPE, GASTROENTEROLOGY-UROLOGY
Product CodeODF
Date Received2013-07-24
Model NumberM00546230
Catalog Number4623
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC - MARLBOROUGH
Manufacturer Address100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-07-24

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