MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DS; LED LIGHT SOURCE

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 11/28/2022

Event Type  Injury  

Manufacturer Narrative

(senior nurse endoscopy phone number): senior nurse endoscopy: (b)(6).The complainant was unable to report the upn and serial number; therefore the unique identifier (udi) #, manufacture date, and expiration date are unknown.(b)(4).

Event Description

Note: note: this report pertains to the spyscope ds ii access & delivery catheter and spyglass ds controller used during the same procedure.Refer to manufacturer report# 3005099803-2022-07963 for the spyscope ds ii access & delivery catheter and for the spyglass ds controller.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and spyglass ds controller were used during a cholangiopancreatography examination procedure performed on (b)(6) 2022.During the procedure, the spyscope ds ii did not work.They made several attempts; however, it was unsuccessful.Another technique was performed during the examination which was guided by rx device.It was reported that the patient's health condition was severe that required life-sustaining intervention.Vasoactive medications were given, orotracheal intubation and surgical intervention was performed by the physician.No further information has been obtained despite good faith efforts.

• Brand Name: SPYGLASS DS
• Type of Device: LED LIGHT SOURCE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): ENERCON TECHNOLOGIES; 25 northbrook dr; gray ME 04039
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16199692
• MDR Text Key: 307658853
• Report Number: 3005099803-2023-00001
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/18/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2022
• Initial Date FDA Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other