MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER GEMINI¿; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	M0063301040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual analysis of the returned device revealed that the pull wire was not broken and the basket assembly does not have any visual issue.The handle cannula was found detached, however, it was properly crimped.The handle cap was unscrewed from the handle and was not returned.Also, the handle locator block was removed from the handle assembly and it was not returned.The evaluation revealed that the handle cannula was detached.However, it is uncertain how the handle cannula was detached.Additionally, as per complaint information the device was used in the esophagus, the directions for use provided with this device states the following in the indications for use/intended use section: "the helical stone retrieval basket is used endoscopically to entrap and remove calculi and other foreign objects from the ureter".Since the device was used contrary to its intended purpose according to the directions for use, this would be considered a user error.Therefore, the most probable root cause for the encountered failure is undeterminable.Since some components were not returned which limits the analysis of the device.The device history record review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a gemini stone retrieval basket was used in the esophagus during a bronchoscopy procedure to remove a foreign body that was performed on (b)(6) 2017.According to the complainant, during the procedure & outside the patient, it was found that pull wire was broken when the device was removed from the package.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: GEMINI¿
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6535888
• Report Number: 3005099803-2017-01189
• Device Sequence Number: 19152238
• Product Code: FFL
• UDI-Device Identifier: 08714729087397
• UDI-Public: (01)08714729087397(17)20180831(10)18340753
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2017

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 Expiration Date: 08/31/2018
• Device Model Number: M0063301040
• Device Catalogue Number: 330-104
• Device Lot Number: 18340753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2017
• Initial Report FDA Received Date: 05/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1