MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH SPYGLASS DIRECT VISUALIZATION SYSTEM; MINI ENDOSCOPE, GASTROENTEROLOGY-UROLOGY

Model Number	M00546230
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a spyglass direct visualization system was used during a spyglass endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during preparation, the fiber was difficult to advance and the catheter had foreign matter which blocked the view of the device.The foreign matter could not be confirmed.The procedure was completed with another spyglass direct visualization system.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.
Additional Manufacturer Narrative
A visual examination of the returned device found that the device appeared to be in good condition with no obvious visual deformities.A spybite was used to verify the complaint; when an attempt was made to pass the spybite, it met resistance near the handle and the distal end, but the spybite was able to pass in both cases.A spyglass was used to look for foreign material in both the working channel and the optic channel; none was found.A guidewire was inserted into the distal end of the working channel and the guidewire exited the working port without issue.The investigation concluded that product analysis could not confirm that foreign matter was present in either the working channel or the optic channel; however, difficulty passing the accessory was confirmed when resistance was met in the handle and the distal end of the device.The most probable root cause is undeterminable.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a spyglass direct visualization system was used during a spyglass endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during preparation, the fiber was difficult to advance and the catheter had foreign matter which blocked the view of the device.The foreign matter could not be confirmed.The procedure was completed with another spyglass direct visualization system.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: SPYGLASS DIRECT VISUALIZATION SYSTEM
• Common Device Name: MINI ENDOSCOPE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 6916793
• Report Number: 3005099803-2017-02914
• Device Sequence Number: 16504858
• Product Code: ODF
• UDI-Device Identifier: 08714729764434
• UDI-Public: 08714729764434
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K090170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2019
• Device Model Number: M00546230
• Device Catalogue Number: 4623
• Device Lot Number: 0000049757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1