MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER SPYSCOPE DS ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00546600

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

The lot number was not reported therefore the manufacture date and expiration date are unknown.Report source: literature.Conference abstract: cholangioscopy is safe and feasible in elderly patients.Presentation number: (b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in a study of cholangioscopy in the evaluation of the safety of ercp in elderly patients.According to the complainant, this is a retrospective study of all ercp with a single operator cholangioscopy (spyglass tm) conducted at two tertiary referral hospitals from march 2014 to october 2015.The demographic data, procedures' indication, findings and complications were collected.The cohort was divided into three groups of patients; the first group included patients under 65 years old, the second group included 65 to 75 year old patients and third group included those above 75 years.The study found that twelve patients experienced adverse events that included bleeding in two patients, cholangitis in one patient, perforation in two patients, pancreatitis in five patients, and two with other complications.The abstract did not provide any additional information regarding the patients involved in the study.

Event Description

It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in a study of cholangioscopy in the evaluation of the safety of ercp in elderly patients.According to the complainant, this is a retrospective study of all ercp with a single operator cholangioscopy (spyglass tm) conducted at two tertiary referral hospitals from march 2014 to october 2015.The demographic data, procedures' indication, findings and complications were collected.The cohort was divided into three groups of patients; the first group included patients under 65 years old, the second group included 65 to 75 year old patients and third group included those above 75 years.The study found that twelve patients experienced adverse events that included bleeding in two patients, cholangitis in one patient, perforation in two patients, pancreatitis in five patients, and two with other complications.The abstract did not provide any additional information regarding the patients involved in the study.

• Brand Name: SPYSCOPE DS ACCESS & DELIVERY CATHETER
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5684233
• MDR Text Key: 46062467
• Report Number: 3005099803-2016-01489
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2016
• Initial Date FDA Received: 05/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other