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

Model Number	M00562531
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 profile extra small oval snare was used during a cold polypectomy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the snare loop had difficulty cutting through the target polyp causing a hematoma.No additional intervention was required to treat the hematoma.The procedure was completed with this device after applying cautery.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
Visual evaluation of the returned device found no anomalies.Functional analysis was performed and the device passed the retroflex test, it extends and retracts within specification.The complaint that the device failed to cut was not confirmed.Evaluation of the returned device found no evidence of either the alleged issue, or any defect which could have contributed to the event.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 profile extra small oval snare was used during a cold polypectomy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the snare loop had difficulty cutting through the target polyp causing a hematoma.No additional intervention was required to treat the hematoma.The procedure was completed with this device after applying cautery.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.

• 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: 6786103
• Report Number: 3005099803-2017-02476
• Device Sequence Number: 1246418
• Product Code: FDI
• UDI-Device Identifier: 08714729156628
• UDI-Public: (01)08714729156628(17)20200502(10)0020593680
• 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): 07/25/2017

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: 05/02/2020
• Device Model Number: M00562531
• Device Catalogue Number: 6253
• Device Lot Number: 0020593680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1