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

Model Number	M00546550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.(b)(4).The complainant indicated that the device has been disposed and will not be returned for evaluation; therefore a problem 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 in the bile duct during a percutaneous bile duct exploration with stone removal procedure performed on (b)(6) 2021.During the procedure, the physician noticed a leaking of contrast medium into the peritoneum indicating a small gallbladder perforation during multiple stone extractions with the spyglass retrieval basket.The physician placed an external/internal drain and will bring the patient back in a week or two to remove further stones.The procedure was successfully completed.It was reported that the patient is expected to fully recover.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a spybasket was used in the bile duct during a percutaneous bile duct exploration with stone removal procedure performed on (b)(6), 2021.During the procedure, the physician noticed a leaking of contrast medium into the peritoneum indicating a small gallbladder perforation during multiple stone extractions with the spyglass retrieval basket.The physician placed an external/internal drain and it was indicated that the patient would be brought back in a week or two after the procedure date to further remove stones.It was reported that the patient is expected to fully recover.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.Block h6 (patient codes): patient code e2114 captures the reportable event of perforation.Block h6 (evaluation conclusion codes): conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device has been disposed and will not be returned for evaluation; therefore a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Corrections: corrections made to b5 (describe event or problem) and h6 (impact codes).

• 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: 11705564
• Report Number: 3005099803-2021-01871
• Device Sequence Number: 19916134
• Product Code: PTS
• UDI-Device Identifier: 08714729965886
• UDI-Public: 08714729965886
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00546550
• Device Catalogue Number: 4665
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 05/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention