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

Model Number M00546650

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 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

(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

Note: this report pertains to the spyscope ds ii access & delivery catheter and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and spyglass ds controller were used during a spyglass procedure perforned in the bile duct on (b)(6) 2021.During the procedure, the image transmitted by the spyscope began to look pixelized and jerky, then blue stripes appeared on it.After that, the image was completely lost.The controller was rebooted, the spyscope and controller connections were cleaned; however, it no longer worked.No more light, no more images, no boston scientific panel when turned on.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Event Description

Note: this report pertains to the spyscope ds ii access & delivery catheter and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and spyglass ds controller were used during a spyglass procedure perforned in the bile duct on (b)(6), 2021.During the procedure, the image transmitted by the spyscope began to look pixelized and jerky, then blue stripes appeared on it.After that, the image was completely lost.The controller was rebooted, the spyscope and controller connections were cleaned; however, it no longer worked.No more light, no more images, no boston scientific panel when turned on.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (device codes): medical device problem code a27 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned spyglass ds digital controller was analyzed by enercon technologies, and a visual evaluation noted that the front panel was scuffed.The top cover had scratches.The rear bumper was cracked.A functional evaluation noted that the catheter interface contacts waere contaminated with unknown material/residue.The connector socket assembly was cleaned.The catheter interface contacts, front panel, keypad, top cover, cover gasket, 32 conductor flex cable and rear bumper were replaced.Light engine calibration was performed and a test was ran.An electrical safety test was performed and the unit passed all tests.The reported event was confirmed.Upon analysis, the front panel was scuffed and top cover had scratches.Catheter interface contacts were contaminated with unknown material/residue.A risk review confirms this is not a new or unanticipated event.The problem is unlikely related to manufacturing, as product analysis identified problems related to use and maintenance and did not identify any manufacturing defect.In addition, during a device history record review conducted by enercon, it was confirmed that the device met all manufacturing specifications.Although the number of procedures/recycles of the unit are unknown, improper handling of the device, cleaning the single use device (sud) port between use or wear/tear on internal components over time likely contributed to the event.Based on all gathered information, the most probable root cause of this event complaint is cause traced to maintenance.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaint exist for the specified lot.

• Brand Name: SPYGLASS DS
• Type of Device: LED LIGHT SOURCE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11986170
• MDR Text Key: 255859595
• Report Number: 3005099803-2021-02820
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• Combination Product (y/n): N
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00546650
• Device Catalogue Number: 4665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Date Manufacturer Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1