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

Model Number M00546600

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 ds access and delivery catheter was used in the bile duct during a cholangioscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, it was noticed that the working channel sleeve of the spyscope ds protruded.Reportedly, no part of the device detached.The procedure was completed with this device.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.

Manufacturer Narrative

A visual assessment was performed after disinfection.The catheter was kinked in several areas near the distal end.The working channel sleeve extended from the distal cap as received, confirming the complaint.The proximal end of the distal cap was aligned to the cap weld.There was evidence of the production bonding process and the application of heat to the outside of the catheter during manufacturing assembly, as seen in the working channel sleeve reflow/bond.A functional assessment was performed.The device was fully articulated in all directions.A.035¿ guidewire was back-loaded through the distal end of the scope.A spybite was passed though the working channel.The distal end of the catheter was removed to examine the working channel.The distal cap was removed from the catheter for examination.The distal end of the exposed working channel sleeve was tugged; it did not detach from the catheter.The catheter was cut open to expose the working channel sleeve.The catheter was pulled back to assess the adhesion of the working channel sleeve to the pebax; the proximal end of the working channel sleeve appeared to be attached to the pebax (bonded length).The working channel sleeve did not fall out; the working channel sleeve was pulled out of the catheter.There was evidence of adhesion of the working channel sleeve to the inside of the catheter, as seen by the white area on the proximal end of the pebax and the working channel sleeve braid imprint throughout the pebax region.The complaint was consistent with the reported event of working channel sleeve protruding.Based on the investigation and the receipt condition/functionality, the complaint investigation conclusion code selected for the working channel sleeve protrusion issue is manufacturing process design.There is an investigation in place to address this issue.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no similar complaints exist for the specified batch.

Event Description

It was reported to boston scientific corporation that a spyscope ds access & delivery catheter was used in the bile duct during a cholangioscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, it was noticed that the working channel sleeve of the spyscope ds protruded.Reportedly, no part of the device detached.The procedure was completed with this device.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.

• Brand Name: SPYSCOPE DS ACCESS & DELIVERY CATHETER
• Type of Device: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7148530
• MDR Text Key: 96051875
• Report Number: 3005099803-2017-03680
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

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: 08/10/2019
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 20996039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 02/06/2018
• Supplement Dates FDA Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2017
• 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
• Patient Age: 54 YR