MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYSCOPE DS; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M00546600

Device Problems Connection Problem (2900); Material Protrusion/Extrusion (2979); Optical Problem (3001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.Problem code captures the reportable investigation results of working channel sleeve protrusion.A visual evaluation was performed.The catheter demonstrated signs of use.As received, the working channel sleeve did not protrude.However, maximum working channel sleeve protrusion was observed when the small knob was turned in the counterclockwise direction and the large knob was turned in the clockwise direction.The device was plugged into the controller.The image was lost intermittently, confirming the reported complaint of loss of visualization.There was no issue connecting the umbilicus to the controller; wiggling on the umbilicus and umbilicus cord did not produce any change in the image.Therefore, the reported complaint of connection issue was not confirmed.The distal tip was cut.The distal cap was removed.The catheter was cut open using the cutting fixture.The total working channel sleeve length was measured.The unbonded length was measured.The working channel sleeve was removed.Witness marks were noted on the pebax.The white and clear areas along bond a appear to show evidence of adhesion.It was found during the investigation of the returned spyscope ds that the working channel sleeve was protruding.Based on the investigation results, the underlying cause of working channel sleeve protrusion is an insufficient bond, particularly the second heat cycle of the working channel sleeve bonding process [bond b].Wcs protrusion in devices manufactured with post 01mar2018 changes has been determined to be a design issue.Therefore, the complaint investigation conclusion code selected for the wcs protrusion issue is design inadequate for purpose, which indicates that problems were traced to design/design features of the device that do not support or do interfere with the intended purpose of the device.An investigation is underway to address this issue.A device history record (dhr) review was performed, and did not identify evidence of deviations or non-conformances in the manufacturing processes that could contribute to the complaint.The dhr review confirms that the accepted device met all manufacturing specifications.

Event Description

It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the bile duct during a cholangioscopy procedure performed on (b)(6) 2018.According to the complainant, about 30 minutes into the procedure, visualization was lost.However, when the physician wobbled the white plug of the scope, the image would display briefly.The procedure was completed with a second spyscope digital access and delivery catheter.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation results; working channel sleeve protrusion.

• Brand Name: SPYSCOPE DS
• 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: 7932214
• MDR Text Key: 122645315
• Report Number: 3005099803-2018-60714
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729863236
• UDI-Public: 08714729863236
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2018

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 Expiration Date: 03/22/2020
• Device Model Number: M00546600
• Device Catalogue Number: 47060
• Device Lot Number: 0021903414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2018
• 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