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

Model Number	M00562531
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	03/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received but an evaluation has not yet been performed; therefore, a failure analysis is not available.If there is any further relevant information received, a supplemental medwatch report will be filed.At this time, we are unable to determine the relationship between the device and the cause for the event.
Event or Problem Description
It was reported to boston scientific corporation that a profile extra small oval snare was used during a colonic polypectomy procedure performed on (b)(6) 2017.According to the complainant, during preparation a human hair was noted inside the sterile packaging.The procedure was completed with another profile snare.There were no patient complications at the conclusion of this procedure and the patient was reported to be fine.
Additional Manufacturer Narrative
Investigation results: visual inspection of the returned device found a hair inside the sealed package.The investigation confirmed the presence of a hair inside the pouch; the most probable root cause for this event 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 similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a profile extra small oval snare was used during a colonic polypectomy procedure performed on (b)(6) 2017.According to the complainant, during preparation a human hair was noted inside the sterile packaging.The procedure was completed with another profile snare.There were no patient complications at the conclusion of this procedure and the patient was reported to be fine.

• Brand Name: PROFILE¿
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6479498
• Report Number: 3005099803-2017-00929
• Device Sequence Number: 1054165
• Product Code: FDI
• UDI-Device Identifier: 08714729156628
• UDI-Public: (01)08714729156628(17)20191206(10)0020047572
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2017

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: 12/06/2019
• Device Model Number: M00562531
• Device Catalogue Number: 6253
• Device Lot Number: 0020047572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2017
• Supplement Report FDA Received Date: 05/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1