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

Model Number M0063302080

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2020

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 from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a gemini retrieval basket was used in the ureter during a ureteroscopy (urs) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noticed that the end of the tube is cracked and the basket comes out with difficulty.The procedure was completed with this device.There were no patient complications as a result of this event.

Event Description

It was reported to boston scientific corporation that a gemini retrieval basket was used in the ureter during a ureteroscopy (urs) procedure performed on (b)(6), 2020.According to the complainant, during the procedure, it was noticed that the end of the tube is cracked and the basket comes out with difficulty.The procedure was completed with this device.There were no patient complications as a result of this event.

Manufacturer Narrative

Block h6: device code 4008 captures the reportable event of sheath torn at distal end.Block h10: visual inspection of the returned device found the distal section of the sheath was torn/split.Functional inspection was performed and found the basket could be extended and retracted without any difficulty.Based on all available information, the investigation concluded that procedural or anatomical factors encountered during procedure could have affected device's performance and integrity.Handling and manipulation of the device and also interaction with additional instruments/tools could have contributed with the observed issue.Therefore, the most probable root cause is adverse event related to the 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.A labeling review was performed and found the device was used in a manner inconsistent with the directions for use (dfu).Per complaint information the customer used the device even though it was damaged.The dfu cited "precaution: before using, inspect the blister pouch for any breach of the package to ensure a sterile product and inspect product for any damage.If seal has been broken or product is damaged do not use.Immediately return package and product to boston scientific.".

• Brand Name: GEMINI
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9726838
• MDR Text Key: 190374987
• Report Number: 3005099803-2020-00463
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729069690
• UDI-Public: 08714729069690
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2022
• Device Model Number: M0063302080
• Device Catalogue Number: 330-208
• Device Lot Number: 0024442215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1