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

Model Number	M00546550
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	09/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a spyglass retrieval basket was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure with cholangioscopy and stone removal performed in the common bile duct on (b)(6) 2018.According to the complainant, during the procedure, the spyglass retrieval basket was passed into the pancreatic duct to remove stone fragments.Stones were removed on the first pass.During the second pass, stones were collected in the basket.During removal of the basket, the basket became impacted in the papillary orifice.Upon removal of the spyscope and duodenal scope from the patient, the internal wire of the catheter broke completely and detached and separated approximately 10 cm proximal to the basket, leaving the basket in the papillary orifice.The catheter and scope were removed from the patient.The physician completed the procedure by using ehl and laser lithotripsy to break up the impacted stones in the basket and removed the basket using a rat-tooth forceps.Everything was successfully removed from the patient.A pancreatic duct stent was placed and the patient is currently in recovery post procedure.There were no patient complications reported as a result of this event.

• Brand Name: SPYGLASS RETRIEVAL BASKET
• Common Device Name: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 7928107
• Report Number: 3005099803-2018-60479
• Device Sequence Number: 11193088
• Product Code: PTS
• UDI-Device Identifier: 08714729965886
• UDI-Public: 08714729965886
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/02/2018

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: 06/19/2020
• Device Model Number: M00546550
• Device Catalogue Number: 4655
• Device Lot Number: 0022276333
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 10/02/2018
• 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: 62 YR