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

Model Number	M00546550
Medical Device Problem Codes	Difficult to Advance (2920); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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
Note: this report pertains to a spyscope ds ii access & delivery catheter and spyglass retrieval basket used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and spyglass retrieval basket were used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the spybasket was unable to advance through the spyscope ds ii.Reportedly, the spybasket got stuck approximately 5-10 cm from the distal tip of the spyscope ds ii.Reportedly, the duodenoscope and spyscope ds ii were straightened to try to help move the accessory devices through; however, this did not resolve the problem.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
Event or Problem Description
Note: this report pertains to a spyscope ds ii access & delivery catheter and spyglass retrieval basket used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and spyglass retrieval basket were used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2021.According to the complainant, during the procedure, the spybasket was unable to advance through the spyscope ds ii.Reportedly, the spybasket got stuck approximately 5-10 cm from the distal tip of the spyscope ds ii.Reportedly, the duodenoscope and spyscope ds ii were straightened to try to help move the accessory devices through; however, this did not resolve the problem.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes): problem code a27 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned spyglass retrieval basket was analyzed, and a visual evaluation noted that the basket was in the closed position when received.The working length was kinked in several locations.The outer diameter of the sheath was measured in three points and the measurements were found within manufacturing specifications.The reported complaint was confirmed.Upon analysis, it was determined that the working length was kinked in several locations; this condition would cause problems to advance the device through the scope.It is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Handling and manipulation of the device during its use can kink the device, also interaction with the scope could have kinked it.Once working length is kinked, this can cause some friction/difficulty to advance the device through the scope.Based on all gathered information, the most probable cause for this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.

• Brand Name: SPYGLASS RETRIEVAL BASKET
• 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: 11306761
• Report Number: 3005099803-2021-00461
• Device Sequence Number: 19654888
• Product Code: PTS
• UDI-Device Identifier: 08714729965886
• UDI-Public: 08714729965886
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

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: 09/30/2022
• Device Model Number: M00546550
• Device Catalogue Number: 4655
• Device Lot Number: 0026108288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1