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

Model Number M0063902010

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that an escape basket was used in the ureter during a ureteroscopy (urs) procedure performed on (b)(6) 2021.During preparation, the pull wire at the proximal end near the handle broke, and the basket failed to open.The proximal end of the sheath was also torn.The procedure was completed with another escape basket.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: device code a0401 captures the reportable event of pull wire break.Block h10: photos of the complaint device was observed and found the sheath was torn at the proximal section adjacent to the head shrink and was out of its original pouch.Visual analysis found the sheath was torn adjacent to the head shrink, and was kinked in the middle.No other issues was noted with the device.The reported event of pull wire broken was not confirmed.Based on all available information, it is possible that the handling or manipulation, excess force applied, and interaction with other device could have caused the sheath to kinked.Once kinked, the friction cause when the user actuated the handle could have cause the sheath to tear and consequently affect the performance of the device.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

Event Description

It was reported to boston scientific corporation that an escape basket was used in the ureter during a ureteroscopy (urs) procedure performed on (b)(6) 2021.During preparation, the pull wire at the proximal end near the handle broke, and the basket failed to open.The proximal end of the sheath was also torn.The procedure was completed with another escape basket.There were no patient complications reported as a result of this event.

• Brand Name: ESCAPE
• Type of Device: 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12589787
• MDR Text Key: 275182640
• Report Number: 3005099803-2021-05188
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729121299
• UDI-Public: 08714729121299
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2023
• Device Model Number: M0063902010
• Device Catalogue Number: 390-201
• Device Lot Number: 0025114415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 10/07/2021
• Supplement Dates Manufacturer Received: 02/14/2022
• Supplement Dates FDA Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male