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

Model Number	M00546550
Medical Device Problem Codes	Break (1069); Difficult to Open or Close (2921); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	05/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a spyglass retrieval basket was used in the main pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp), cholangioscopy guided litothripsy and pancreatic stone removal procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a dilation was performed with a soehendra dilator narrowing the distal of the stone in the main pancreatic duct.Cholangioscopy and lithotripsy were then performed using a spyscope ds ii and an aulotilth onetouch ehl (electrohydraulic lithotripsy) probe, which was not successful.The autolith probe was not powerful enough to crash the stone.Reportedly, 260 pulses of ehl were delivered when attempting to break up the stone.As a result, a spybasket was attempted to be used to extract the stone.However, the stone and the spybasket got impacted.After multiple attempts to pull the stone; the handle of the spybasket got broken.Reportedly, the physician applied too much force while trying to pull the basket out of the duct.The handle detached from the wire and it remained inside of the patient's biliary system.An argon plasma coagulator was used to cut the spybasket and attempted to pull the device and stone out but was not successful.The impacted spybasket remained inside the patient and the procedure was not completed due to this event.A surgery was performed the day after and reportedly, the spybasket was removed from the patient successfully.The patient's current condition was reported to be recovering and feeling good.

• 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: 10170178
• Report Number: 3005099803-2020-02351
• Device Sequence Number: 2142819
• Product Code: PTS
• UDI-Device Identifier: 08714729965886
• UDI-Public: 08714729965886
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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
• Report Date (Section B): 06/18/2020

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: 11/28/2020
• Device Model Number: M00546550
• Device Catalogue Number: 4655
• Device Lot Number: 23007136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2020
• Initial Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR