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 Hemorrhage/Bleeding (1888)

Event Date 02/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the biliary duct during a cholangioscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the spyscope ds lost visualization.A second spyscope ds was opened and inserted over a jagwire guidewire into the bile duct.They had good visualization; however, the working channel sleeve of the second spyscope ds suddenly protruded and hit the biliary tree which caused a minor bleed.Reportedly, there was no medical intervention required to address the bleed.The procedure was completed with a third spyscope digital access and delivery catheter.The patient's condition at the end of the procedure was reported to be stable.

Manufacturer Narrative

Visual assessment was performed.As received, the working channel sleeve (wcs) did not protrude.However, maximum wcs protrusion was observed when the distal tip was articulated by turning the small knob in the counterclockwise direction and the large knob in both directions.The distal tip was cut.The distal cap was removed.The catheter was cut open using the cutting fixture.The wcs was removed.Witness marks were noted on the pebax.The white and clear areas along bond a appeared to show evidence of adhesion.The complaint was consistent with the reported complaint incident of working channel sleeve protruding.Based on 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].Working channel sleeve protrusion in devices manufactured post 01mar2018 changes has been determined to be a design issue, therefore, the complaint investigation conclusion code selected for the working channel sleeve 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 dhr (device history record) 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 biliary duct during a cholangioscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the spyscope ds lost visualization.A second spyscope ds was opened and inserted over a jagwire guidewire into the bile duct.They had good visualization; however, the working channel sleeve of the second spyscope ds suddenly protruded and hit the biliary tree which caused a minor bleed.Reportedly, there was no medical intervention required to address the bleed.The procedure was completed with a third spyscope digital access and delivery catheter.There were no patient complications reported as a result of this event.The patient's condition at the end of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the biliary duct during a cholangioscopy procedure performed on (b)(6), 2019.According to the complainant, during the procedure, the spyscope ds lost visualization.A second spyscope ds was opened and inserted over a jagwire guidewire into the bile duct.They had good visualization; however, the working channel sleeve of the second spyscope ds suddenly protruded and hit the biliary tree which caused a minor bleed.Reportedly, there was no medical intervention required to address the bleed.The procedure was completed with a third spyscope digital access and delivery catheter.The patient's condition at the end of the procedure was reported to be stable, and there was no problem with the patient.

Manufacturer Narrative

(b)(4).Block h10: visual assessment was performed.As received, the working channel sleeve (wcs) did not protrude.However, maximum wcs protrusion was observed when the distal tip was articulated by turning the small knob in the counterclockwise direction and the large knob in both directions.The distal tip was cut.The distal cap was removed.The catheter was cut open using the cutting fixture.The wcs was removed.Witness marks were noted on the pebax.The white and clear areas along bond a appeared to show evidence of adhesion.The complaint was consistent with the reported complaint incident of working channel sleeve protruding.Based on 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].Working channel sleeve protrusion in devices manufactured post 01mar2018 changes has been determined to be a design issue, therefore, the complaint investigation conclusion code selected for the working channel sleeve 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 dhr (device history record) 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.

• 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
• MDR Report Key: 8374872
• MDR Text Key: 137292423
• Report Number: 3005099803-2019-00992
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729863236
• UDI-Public: 08714729863236
• 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,Followup
• Report Date: 05/15/2019

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: 09/30/2020
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 22732214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 02/27/2019
• Supplement Dates Manufacturer Received: 03/21/2019; 04/23/2019
• Supplement Dates FDA Received: 04/15/2019; 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR