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

Model Number	M0063902000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two potential lot numbers were reported, and the customer was unable to confirm which pertains to the complaint device: 22018659 or 21556473.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.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 an escape basket was used during a procedure on an unknown date.According to the complainant, during the procedure, the basket detached but could be recovered.No patient complications were reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported to boston scientific corporation that an escape basket was used during a procedure on an unknown date.According to the complainant, during the procedure, the basket detached but could be recovered.No patient complications were reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information received as of 19jul2019*** during a flexible ureteroscopy procedure, the basket wires broke and detached.The broken wires were removed from the patient the day after the procedure using another basket.
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Two potential lot numbers were reported, and the customer was unable to confirm which pertains to the complaint device: (b)(4).Additional information - b1, b2, b5, d8, h8.Device code 2907 captures the reportable event of basket wire break.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Additional Manufacturer Narrative
Block d4, h4: two potential lot numbers were reported, and the customer was unable to confirm which pertains to the complaint device: 22018659 or 21556473.Block h6: device code 2907 captures the reportable event of basket detached.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.Block h11: correction: block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.
Event or Problem Description
It was reported to boston scientific corporation that an escape basket was used during a procedure on an unknown date.According to the complainant, during the procedure, the basket detached but could be recovered.No patient complications were reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: ESCAPE
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8793001
• Report Number: 3005099803-2019-03599
• Device Sequence Number: 16654962
• Product Code: FFL
• UDI-Device Identifier: 08714729121282
• UDI-Public: 08714729121282
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2019

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: 04/19/2021
• Device Model Number: M0063902000
• Device Catalogue Number: 390-200
• Device Lot Number: 0022018659
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 07/16/2019; 07/19/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 07/17/2019; 08/14/2019
• 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: Hospitalization; Required Intervention