MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) SENSATION¿ SHORT THROW; SNARE, FLEXIBLE

Model Number	M00560321
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 sensation small oval snare was prepared to be used during a polypectomy procedure performed on (b)(6) 2017.According to the complainant, during preparation, a yellow foreign matter was noted on the tip connection of the handle through the sealed pouch.The procedure was completed with another sensation snare.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 okay.
Additional Manufacturer Narrative
Visual evaluation of the returned device found that the unused snare was in a sealed pouch and the sterile barrier was intact.Further examination noted a yellow stain in the cap connector.The reported complaint that a yellow foreign matter was noted in the cap connector was confirmed.The most probable root cause of this complaint is manufacturing.An investigation to address this issue has been completed.A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database revealed that no other complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a sensation small oval snare was prepared to be used during a polypectomy procedure performed on (b)(6) 2017.According to the complainant, during preparation, a yellow foreign matter was noted on the tip connection of the handle through the sealed pouch.The procedure was completed with another sensation snare.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 okay.

• Brand Name: SENSATION¿ SHORT THROW
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6846040
• Report Number: 3005099803-2017-02698
• Device Sequence Number: 1117323
• Product Code: FDI
• UDI-Device Identifier: 08714729283928
• UDI-Public: (01)08714729283928(17)20200326(10)20454272
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K941750
• 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
• Report Date (Section B): 08/21/2017

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: 03/26/2020
• Device Model Number: M00560321
• Device Catalogue Number: 6032
• Device Lot Number: 20454272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1