MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS? RETRIEVAL BASKET; DISLODGER, STONE, BILIARY

Model Number	M00546550
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Open or Close (2921)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block g2: fda report number mw5155889 block h6: imdrf device code a051104 captures the reportable event of basket failure to release stone.Imdrf patient code e2008 captures the reportable event of basket remained inside the patient's bile duct after original procedure.Imdrf impact code f2202 captures the event of repeat ercp to remove the basket from the bile duct.
Event or Problem Description
It was reported to boston scientific corporation that a spyglass retrieval basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, two autolith electrohydraulic lithotripsy (ehl) probes were used to attempt to crush a stone approximately 4-5 cm in size but was unsuccessful.A spyglass retrieval basket was then used; however, the basket was unable to crush the stone and became embedded in the basket.Multiple attempts were made with different devices to remove the stone but failed.The procedure was aborted due to concern for bile duct injury and length of procedure time.The basket wire was cut at the patient's mouth and the basket with the stone remained inside the duct.The patient was hospitalized and scheduled for another procedure to remove the stone and basket.On (b)(6) 2024, the patient was sent for another ercp.Spy and ehl were used to remove the basket and stone from the bile duct without complications.
Event or Problem Description
It was reported to boston scientific corporation that a spyglass retrieval basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, two autolith electrohydraulic lithotripsy (ehl) probes were used to attempt to crush a stone approximately 4-5 cm in size but was unsuccessful.A spyglass retrieval basket was then used; however, the basket was unable to crush the stone and became embedded in the basket.Multiple attempts were made with different devices to remove the stone but failed.The procedure was aborted due to concern for bile duct injury and length of procedure time.The basket wire was cut at the patient's mouth and the basket with the stone remained inside the duct.The patient was hospitalized and scheduled for another procedure to remove the stone and basket.On (b)(6) 2024, the patient was sent for another ercp.Spy and ehl were used to remove the basket and stone from the bile duct without complications.
Additional Manufacturer Narrative
Note: this report was amended to update international medical device regulators forum (imdrf) codes.Incomplete coding of this event was identified during a retrospective review of complaints associated with capa-8580, which focused on identifying and remediating incomplete coding of events.Block h2 block h6 has been corrected.Block g2: fda report number mw5155889.Block h6: imdrf device code a051104 captures the reportable event of basket failure to release stone.Imdrf patient code e2008 captures the reportable event of basket remained inside the patient's bile duct after original procedure.Imdrf impact code f2202 captures the event of repeat ercp to remove the basket from the bile duct.Imdrf device code a150207 captures the event of device difficult to remove.Block h11: the complaint device was not returned; therefore, product analysis could not be performed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the events of basket failure to release stone, unretrieved device fragments (udf), cancelled/rescheduled-post sedation unknown, hospitalization or prolonged hospitalization, endoscopic procedure, additional device required were defined in the risk documentation and are documented according to the prr.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the information provided, the most probable cause of the reported issues "basket failure to release stone" and "device difficult to remove" cannot be established due to lack of evidence.The product was not returned for analysis to identify any defect with the device.Additionally, without proper evaluation of the device, it remains unknown the most probable causes that contributed to the events.Also, for the events cancelled/rescheduled - post sedation/sedation unknown, hospitalization or prolonged hospitalization, endoscopic procedure and additional device required, they happened during the procedure, and the most probable cause of those reported issues cannot be established due to lack of evidence.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• Brand Name: SPYGLASS? RETRIEVAL BASKET
• Common Device Name: DISLODGER, STONE, BILIARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 19834466
• Report Number: 3005099803-2024-03506
• Device Sequence Number: 15423241
• Product Code: LQR
• UDI-Device Identifier: 08714729965886
• UDI-Public: 08714729965886
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K071066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: 12/31/2025
• Device Model Number: M00546550
• Device Catalogue Number: M00546550
• Device Lot Number: 0033117638
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 04/21/2026
• Date Device Manufactured: 01/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Hispanic
• Patient Race: White