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 Patient Involvement (2645)

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 & delivery catheter was used in a bench top model during a endoscopic retrograde cholangiopancreatoscopy (ercp) procedure performed on (b)(6) 2017.According to the complainant, during procedure, while passing a spybite biopsy forceps and new accessories for the spyscope ds, it was noticed that the working channel sleeve protruded and blocked the field of vision.Reportedly, no part of the device detached.The procedure was completed with this device.There was no patient involvement and the device was used in a bench top model that was built similarly to the human biliary system.

Manufacturer Narrative

A visual assessment was performed after disinfection.The working channel sleeve extended from the distal cap when received.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 inspection was performed.The distal tip articulated without issue.A spybite biopsy forceps was passed through the proximal portion of the working channel sleeve; however, the spybite biopsy forceps could not advance due to collapsed, exposed working channel sleeve.A portion of the distal end of the catheter were 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 working channel sleeve did not fall out.After tugging the working channel sleeve out to remove it from the catheter, there was a strong evidence of adhesion of the working channel sleeve to the inside of the catheter, as seen by the proximal portion of the working channel sleeve braid remaining attached to the pebax.The complainant was consistent with the reported event of working channel sleeve protruding.Most likely, the defect was due to anatomical/ procedural factors encountered during the procedure, therefore, the most probable root cause for the working channel protrusion is operational context.A dhr (device history record) review was performed and no deviation was found.

Event Description

It was reported to boston scientific corporation that a spyscope ds access & delivery catheter was used in a bench top model during a endoscopic retrograde cholangiopancreatoscopy (ercp) procedure performed on (b)(6) 2017.According to the complainant, during procedure, while passing a spybite biopsy forceps and new accessories for the spyscope ds, it was noticed that the working channel sleeve protruded and blocked the field of vision.Reportedly, no part of the device detached.The procedure was completed with this device.There was no patient involvement and the device was used in a bench top model that was built similarly to the human biliary system.

• 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: 6740596
• MDR Text Key: 80929273
• Report Number: 3005099803-2017-02168
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729863236
• UDI-Public: (01)08714729863236(17)20181031(10)19841292
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

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: Medical Equipment Company Technician/Representative
• Device Expiration Date: 10/31/2018
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 19841292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/27/2017
• Initial Date FDA Received: 07/25/2017
• Supplement Dates Manufacturer Received: 07/25/2017
• Supplement Dates FDA Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2016
• 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