MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Device Problems Defective Device (2588); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).The complainant was unable to report the upn and lot number; therefore the unique identifier (udi) #, manufacture date, and expiration date are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

This report pertains to an exalt model d scope and two spyscope ds used during the same procedure.It was reported to boston scientific corporation that an exalt model d scope and two spyscope ds were used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021 as part of the e7156 exalt dscope 02 study.During the procedure, the physician experienced technical failure of the two spyscopes and problems with the exalt scope's elevator.The procedure was not completed.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: SPYSCOPE DS
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 80 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13225435
• MDR Text Key: 288488646
• Report Number: 3005099803-2022-00046
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K181439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/11/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male