MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DISCOVER DIGITAL CATHETER

Model Number M00546780

Device Problems Poor Quality Image (1408); Optical Problem (3001); Appropriate Term/Code Not Available (3191)

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

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

Product code: ntn.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.(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

It was reported to boston scientific corporation that a spyglass discover digital catheter was used in the bile duct during a laparoscopic common bile duct exploration (lcbde) procedure performed on (b)(6) 2021.During the procedure, the spyglass discover digital catheter image had lines going through it, then disappeared and the image could not be brought back on the screen.The spyglass discover digital catheter was unplugged and plugged back into the controller; however, the problem was not resolved.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
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13094027
• MDR Text Key: 282825028
• Report Number: 3005099803-2021-07962
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729994183
• UDI-Public: 08714729994183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/28/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/28/2021
• 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