MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS RETRIEVAL SNARE; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number M00546560

Device Problems Mechanical Problem (1384); Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

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

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

(expiration date): the device was expired on february 26, 2021, but the device was used during a procedure on (b)(6) 2021.(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 the two spyscope ds ii, spysnare and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that the two spyscope ds ii, spysnare and spyglass ds controller were used during a cholangioscopy procedure performed in the common bile duct (cbd) on (b)(6) 2021.During the procedure, the image of the first spyscope ds ii was lost less than 5 minutes into the procedure.A second spyscope ds ii was used, however, the image was also lost.An autolith electrohydraulic lithotripsy (ehl) probe was used when the visualization problems occurred.The spyscope ds ii was disconnected and reconnected back to the controller, and the controller was rebooted several times; however, the problem was not resolved.They also tried to used a spysnare, and it failed to open when it was inside the scope and inside the patient.The procedure was rescheduled due to this event.There were no patient complications reported as a result of this event.

• Brand Name: SPYGLASS RETRIEVAL SNARE
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• 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: 11633975
• MDR Text Key: 247708914
• Report Number: 3005099803-2021-01573
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 08714729965893
• UDI-Public: 08714729965893
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2021
• Device Model Number: M00546560
• Device Catalogue Number: 4656
• Device Lot Number: 0023409381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2019
• 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