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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(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.According to the complainant, during the procedure, the snare loop failed to cut the target polyp.The procedure was completed with a different device.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 good.
Additional Manufacturer Narrative
Investigation results: visual evaluation of the returned device revealed that the catheter was twisted and torn near the handle section.Functional analysis showed that the device failed to extend due to the condition of the returned device.The reported complaint that the snare loop failed to cut was confirmed.Due to anatomical/procedural factors encountered during the procedure; performance of the device was limited.Therefore, the most probable root cause classification is operational context.
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.According to the complainant, during the procedure, the snare loop failed to cut the target polyp.The procedure was completed with a different device.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 good.

• 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: 7306691
• Report Number: 3005099803-2018-00487
• Device Sequence Number: 1067033
• Product Code: FDI
• UDI-Device Identifier: 08714729156628
• UDI-Public: 08714729156628
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2018

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: Physician
• Device Model Number: M00562531
• Device Catalogue Number: 6253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1