MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS II ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00546610

Device Problem Positioning Problem (3009)

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

Event Date 09/21/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed for the treatment of intraductal papillary mucinous neoplasm on (b)(6) 2023.During the procedure, the spyscope ds ii was inserted into the working channel of the duodenoscope, and attempt to intubate the pancreatic duct; however, the spyscope ds ii was having difficulty articulating the tip.The device was check outside the patient, and still it was not working.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.

Manufacturer Narrative

Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h10 the returned spyscope ds ii was analyzed, and a visual evaluation noted elevator marks on the shaft of the catheter.Upon plugging the device into the controller, a live image was displayed.The catheter was able to be articulated in all directions except for the counterclockwise direction when the small knob of the steering wheel was used.The handle was opened and the steering wires inside were inspected visually.Visual assessment of the steering wires found damage in the form of a break with one of the steering wires.The reported complaint was confirmed.During product analysis, signs of use in the form of witness marks were noted.A live image was seen upon insertion of the device and the device was able to articulate in all directions except for the counterclockwise direction when the small knob was used.Visual inspection of the steering wires showed that one of the steering wires attached to the large knob broke.Position of the device in anatomy and use of combination devices may have caused the steering wires to be under tension which then contributed to steering wire break during procedure.Based on all gathered information, the probable cause selected for the connection problem is adverse event related to procedure, which indicates that the device complaint or problem occurred during the procedure and the device had no influence on the event.

Event Description

It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter was used in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed for the treatment of intraductal papillary mucinous neoplasm on (b)(6) 2023.During the procedure, the spyscope ds ii was inserted into the working channel of the duodenoscope, and attempt to intubate the pancreatic duct; however, the spyscope ds ii was having difficulty articulating the tip.The device was check outside the patient, and still it was not working.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.

• Brand Name: SPYSCOPE DS II ACCESS & DELIVERY CATHETER
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• 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: 17956323
• MDR Text Key: 326590814
• Report Number: 3005099803-2023-05380
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: 08714729965404
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

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: M00546610
• Device Catalogue Number: 4661
• Device Lot Number: 0031693703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 11/03/2023
• Supplement Dates FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2023
• 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