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

Model Number M00546600

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Patient Involvement (2645)

Event Date 08/27/2018

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).A visual assessment was performed.The catheter demonstrated signs of use.As received, the wcs protruded.A functional assessment for wcs protrusion was performed and maximum wcs protrusion was observed when the small knob was turned in the counter clock wise direction and large knob was turned in the clockwise direction.The distal tip was cut.The distal cap was removed.The catheter was cut open using the cutting fixture.The total wcs length was measured.The unbonded length was measured.The wcs was removed.Witness marks were noted on the pebax.The white areas along bond a appear to show evidence of adhesion.Based on the investigation results, the root cause of working channel sleeve protrusion is an insufficient bond, particularly the second heat cycle of the working channel sleeve bonding process [bond b].The complaint investigation conclusion code selected for the wcs protrusion issue is manufacturing deficiency, which indicates that problems were traced to the manufacturing process.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr history review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.

Event Description

It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was returned in a biohazard bag.There is no further information available regarding this event.This event has been deemed reportable based on the investigation results; working channel sleeve protruded.

• Brand Name: SPYSCOPE DS
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; ,; spencer IN 47460
• Manufacturer Contact: carole morley ; 100 boston scientific way; ,; marlborough, MA 01752-1242 ; 5086834015
• MDR Report Key: 7956204
• MDR Text Key: 123405879
• Report Number: 3005099803-2018-60529
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729863236
• UDI-Public: 08714729863236
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 10/11/2018

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 Model Number: M00546600
• Device Catalogue Number: 47060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1