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 Patient Involvement (2645)
Date of Event	11/27/2017
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 on (b)(6) 2017 that a profile extra small oval snare was checked during inventory.According to the complainant, during unpacking, the catheter was noted to be dirty through the sealed pouch.There was no patient or procedure associated with this event.
Additional Manufacturer Narrative
Investigation results.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 foreign matter was found inside the device.The reported complaint that a foreign matter was found inside the device 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 similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2017 that a profile extra small oval snare was checked during inventory.According to the complainant, during unpacking, the catheter was noted to be dirty through the sealed pouch.There was no patient or procedure associated with this event.

• 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: 7109680
• Report Number: 3005099803-2017-03666
• Device Sequence Number: 1068102
• Product Code: FDI
• UDI-Device Identifier: 08714729156628
• UDI-Public: 08714729156628
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K941750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2017

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: Physician
• Device Expiration Date: 02/01/2020
• Device Model Number: M00562531
• Device Catalogue Number: 6253
• Device Lot Number: 0020237231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1