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

Model Number	M0063301080
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exact patient age unknown, but reported to be over 18 years of age.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 a gemini retrieval basket was used in a ureteroscopy (urs) procedure performed on (b)(6) 2019.According to the complainant, upon opening the basket, the sheath was noted to be broken.Preliminary investigation of the device found that the sheath was torn on the distal end.No patient complications were reported due to 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 Manufacturer Narrative
Exact patient age unknown, but reported to be over 18 years of age.Device code 4008 captures the reportable event of sheath torn at the distal end.Visual analysis of the returned device found the distal section of the sheath was torn/split.As per complaint information, the issue occurred during preparation.It is most likely that handling and manipulation of the device during unpacking/prepping/testing could have contributed with the reported issue.Manufacturing processes include extensive inspections to ensure that all finished devices meet specifications; however, there is no control how the devices are handled/manipulated in the field.Based on the information available and the analysis performed, the investigation conclusion code for the reported complaint will be documented as "adverse event related to procedure." since the adverse event occurred during the procedure and the device had no influence on event.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.Correction to adverse event problem evaluation conclusion codes and device analysis results narrative.
Event or Problem Description
It was reported to boston scientific corporation that a gemini retrieval basket was used in a ureteroscopy (urs) procedure performed on (b)(6) 2019.According to the complainant, upon opening the basket, the sheath was noted to be broken.Preliminary investigation of the device found that the sheath was torn on the distal end.No patient complications were reported due to 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 Manufacturer Narrative
Block a2: exact patient age unknown, but reported to be over 18 years of age.Block h6: device code 4008 captures the reportable event of sheath torn at the distal end.Block h10: visual analysis of the returned device found the distal section of the sheath was torn/split.As per complaint information, the issue occurred during preparation.It is most likely that handling and manipulation of the device during unpacking/prepping/testing could have contributed with the reported issue.Manufacturing processes include extensive inspections to ensure that all finished devices meet specifications; however, there is no control how the devices are handled/manipulated in the field.Based on the information available and the analysis performed, the investigation conclusion code for the reported complaint will be documented as "unintended use error caused or contributed to event" since the interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation.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 labeling review was performed and no anomalies were noted.
Event or Problem Description
It was reported to boston scientific corporation that a gemini retrieval basket was used in a ureteroscopy (urs) procedure performed on (b)(6) 2019.According to the complainant, upon opening the basket, the sheath was noted to be broken.Preliminary investigation of the device found that the sheath was torn on the distal end.No patient complications were reported due to 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: GEMINI
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8847750
• Report Number: 3005099803-2019-03820
• Device Sequence Number: 2515566
• Product Code: FFL
• UDI-Device Identifier: 08714729087410
• UDI-Public: 08714729087410
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 11/19/2019

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: 05/13/2022
• Device Model Number: M0063301080
• Device Catalogue Number: 330-108
• Device Lot Number: 0023787357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 07/31/2019; 10/25/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 08/22/2019; 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1