MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESCAPE; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	M0063902010
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a0401 captures the reportable event of basket wire break.Block h11: investigation results: the device was not returned for analysis; therefore, the reported basket wire detachment could not be confirmed.However, a media analysis was performed on the picture submitted by the customer, and it was found that the sheath of an escape basket was detached/separated.Additionally, the condition of the basket could not be appreciated on the picture provided.Based on the available information it is possible that the observed sheath detachment could be related to handling and manipulation of the device; it is probable that an excess of force applied to the device such as operational factors during use could cause the observed sheath detachment.The most probable cause of the reported issue cannot be established due to lack of evidence.Additionally, without a proper evaluation of the device, it remains unknown the most probable causes that could have contributed to the event.Therefore, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that an escape basket device was used during an endoscopic ureteroplasty procedure.During preparation, the basket wire completely detached from the basket outside the patient.The procedure was completed with another of the same device with no patient complications.
Event or Problem Description
It was reported that an escape basket device was used during an endoscopic ureteroplasty procedure.During preparation, the basket wire completely detached from the basket outside the patient.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a0401 captures the reportable event of basket wire break.Block h11: investigation results, the returned escape basket was analyzed, and a visual evaluation noted that the device returned with the basket on its close position and the handle was in good condition.The black heat shrink of the basket was bent/kinked.Microscopic examination identified that the sheath was torn and detached in the center.Additionally, the sheath was found bent/kinked at the distal section.There was no evidence of basket wire break.Functional examination was performed, and the handle was actuated; however, the basket was unable to open and close due to the detachment.With all the available information, boston scientific concludes that the reported event of basket wire break was not confirmed.However, it was found that the basket had the black heat shrink bent/kinked.Also, the sheath was torn, detached in the center, and it was bent/kinked at the distal section.These could be related to handling and manipulation of the device during preparation.It is probable that an excess of force applied to the device such as operational factors could cause all these damages observed.Based on the analysis results, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.

• Brand Name: ESCAPE
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19930776
• Report Number: 2124215-2024-47939
• Device Sequence Number: 8234592
• Product Code: FFL
• UDI-Device Identifier: 08714729121299
• UDI-Public: 08714729121299
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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 Model Number: M0063902010
• Device Catalogue Number: 390-201
• Device Lot Number: 0033572655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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
• Patient Sex: Male