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 Tissue Damage (2104)

Event Date 12/12/2017

Event Type  Injury  

Manufacturer Narrative

This event was reported to the fda via a voluntary medwatch report.The report number is mw5074299.The complainant indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a spyscope digital access & delivery catheter was used during endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, it was noticed that the working channel sleeve was protruding from the distal end of the spy scope cap causing skin abrasion to the patient.There were no reported patient complications as a result of this event.Customer information is unavailable as the complaint was reported via maude report; therefore, attempts cannot be made to gather additional information regarding the circumstances surrounding this event.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 7281588
• MDR Text Key: 100412091
• Report Number: 3005099803-2018-00349
• 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: health professional,other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2019
• Device Model Number: M00546600
• Device Catalogue Number: 4660
• Device Lot Number: 21316968
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2018
• Initial Date FDA Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1828132-12/22/2017-002-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other