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

Model Number M00546650

Device Problems Optical Problem (3001); Appropriate Term/Code Not Available (3191)

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

Event Date 12/14/2021

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to report the serial number; therefore the 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 mdr will be filed.

Event Description

Note: this report pertains to a spyscope ds ii catheter and a spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii catheter and a spyglass ds controller were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, gray dots appeared and image in and out approximately 4-5minutes into the procedure.The nurse unplugged and plugged the spyscope ds ii and turned the controller on and off, and still no image.The procedure was not completed due to this event.A plastic stent was placed and bring back the patient for another spy case in 2-3 weeks.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to report the serial number; therefore the manufacture date and expiration date are unknown.Block h6 (impact codes): impact code f05 is being used to capture the reportable event of aborted/cancelled procedure.Block h6 (evaluation conclusion codes): conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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 mdr will be filed.

Event Description

Note: this report pertains to a spyscope ds ii catheter and a spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii catheter and a spyglass ds controller were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, gray dots appeared and image in and out approximately 4-5 minutes into the procedure.The nurse unplugged and plugged the spyscope ds ii and turned the controller on and off, and still no image.The procedure was not completed due to this event.A plastic stent was placed and bring back the patient for another spy case in 2-3 weeks.There were no patient complications reported as a result of this event.Additional information was received on january 18, 2022, confirming that the controller worked fine.

• 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; 665; gray ME 04039
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13225486
• MDR Text Key: 284711875
• Report Number: 3005099803-2021-08202
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: M00546650
• Device Catalogue Number: 4665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 01/18/2022
• Supplement Dates FDA Received: 02/08/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male