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

Model Number	M0063903010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported to boston scientific corporation that an optiplex¿ basket was used in an unknown procedure performed on (b)(6) 2017.According to the complainant, the optiflex basket could not be used due to a broken pull wire.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 Manufacturer Narrative
An opti-flex basket was returned for analysis.A visual analysis found that the device was returned in two sections.The sheath and pull wire were found broken at approximately 36 cm from the handle.The broken ends have evidence of bending.Additionally, residue was found caught on the basket wires.The complaint was confirmed.Due to the residue, it is most likely that the device was used in the procedure.Handling and manipulation of the device during procedure can lead to the device becoming bent.Once the device is bent, rotation of the handle can result in pull wire and sheath breakage due to the torsion on the bending area.Additionally, procedural and anatomical factors encountered during the use of the device could have contributed to the encountered failure.Therefore, the most probable root cause of this complaint is "operational context", since due to anatomical and/or procedural factors encountered during the procedure, performance was limited.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.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 an optiplex basket was used in an unknown procedure performed on (b)(6) 2017.According to the complainant, the optiflex basket could not be used due to a broken pull wire.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.Correction on the event description: the correct complaint device reported to boston scientific corporation is optiflex basket.
Event or Problem Description
It was reported to boston scientific corporation that an optiplex¿ basket was used in an unknown procedure performed on (b)(6) 2017.According to the complainant, the optiflex basket could not be used due to a broken pull wire.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.Correction on the event description: the correct complaint device reported to boston scientific corporation is optiflex¿ basket.

• Brand Name: OPTIFLEX¿
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7263363
• Report Number: 3005099803-2018-00388
• Device Sequence Number: 11012365
• Product Code: FFL
• UDI-Device Identifier: 08714729772859
• UDI-Public: 08714729772859
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2018

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: 04/30/2018
• Device Model Number: M0063903010
• Device Catalogue Number: 390-301
• Device Lot Number: 19107513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 02/21/2018; 04/30/2018
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 03/13/2018; 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR