MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DISCOVER DIGITAL CATHETER; Choledochoscope and accessories, flexible/rigid

Model Number M00546780

Device Problems Poor Quality Image (1408); Optical Problem (3001)

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

Event Date 09/16/2023

Event Type  malfunction  

Manufacturer Narrative

D2b: pro code ntn.H6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

Event Description

Note: this report pertains to a spy discover catheter and spy discover controller used during the same procedure.It was reported to boston scientific corporation that a spy discover catheter and a spy discover controller were used during a percutaneous spyglass procedure performed for the treatment of stenosis on (b)(6) 2023.During the procedure, the image from the spy discover catheter was lost at the time of access, the image disconnects and reconnects.They turned on and off the spy discover controller; however, the image problem persists.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.

• Brand Name: SPYGLASS DISCOVER DIGITAL CATHETER
• 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17885851
• MDR Text Key: 325084698
• Report Number: 3005099803-2023-05231
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729994183
• UDI-Public: 08714729994183
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K200483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2023

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
• Device Model Number: M00546780
• Device Catalogue Number: 4678
• Device Lot Number: 0031871782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2023
• Initial Date FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1