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)
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 for use during a procedure.According to the complainant, during preparation, a hair was noted inside the sterile packaging.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 fine.
Event or Problem Description
It was reported to boston scientific corporation that a sensation small oval snare was prepared for use during a procedure.According to the complainant, during preparation, a hair was noted inside the sterile packaging.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 fine.
Additional Manufacturer Narrative
Investigation results: an unused sensation snare was returned for analysis.Visual evaluation of the returned device found that the snare was in a sealed pouch and the sterile barrier was intact.Further examination noted that a hair was found inside the sealed package.The reported complaint that a foreign matter was found inside the sealed pouch was confirmed.The most probable root cause of this complaint is manufacturing-execution error.There is an investigation in place to address this issue.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.

• 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: 7454805
• Report Number: 3005099803-2018-01231
• Device Sequence Number: 806657
• Product Code: FDI
• UDI-Device Identifier: 08714729283928
• UDI-Public: 08714729283928
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2018

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: 11/19/2020
• Device Model Number: M00560321
• Device Catalogue Number: 6032
• Device Lot Number: 0021406285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1