MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS RETRIEVAL SNARE; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number	M00546560
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2020
Type of Reportable Event	Serious Injury
Additional 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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a spyglass retrieval snare was used in the middle and upper bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the spysnare was introduced to remove a non-bsc migrated plastic stent.Reportedly, the distal end of the spysnare detached when it was pulled out with the migrated plastic stent.Reportedly, the entire spysnare (including the snare end) was removed from the patient.The plastic stent was successfully retrieved using a non-bsc polypectomy handle 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.
Additional Manufacturer Narrative
(device codes): problem code 2907 captures the reportable event of loop detached.The returned spysnare was analyzed, and a visual evaluation noted that the distal section of the sheath was kinked in several locations.The snare loop was detached from the hypotube notched.The hypotube notched had evidence of the crimping process.The reported event was confirmed.The issue occurred during the procedure and the device was able to catch the stent.The issue occurred when the user was pulling the device out with the stent.This indicates that likely the device was in good condition.However, procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.Handling and manipulation of the device during its use can lead to kink the sheath.Additionally, user technique and force applied to the device pulling the stent could have contributed with the event.Therefore, the most probable cause of this complaint is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a spyglass retrieval snare was used in the middle and upper bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the spysnare was introduced to remove a non-bsc migrated plastic stent.Reportedly, the distal end of the spysnare detached when it was pulled out with the migrated plastic stent.Reportedly, the entire spysnare (including the snare end) was removed from the patient.The plastic stent was successfully retrieved using a non-bsc polypectomy handle 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: SPYGLASS RETRIEVAL SNARE
• Common Device Name: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9842579
• Report Number: 3005099803-2020-01087
• Device Sequence Number: 2856006
• Product Code: PTS
• UDI-Device Identifier: 08714729965893
• UDI-Public: 08714729965893
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2021
• Device Model Number: M00546560
• Device Catalogue Number: 4656
• Device Lot Number: 24439759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR