MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EZ BENT TIP; TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION

Model Number	7584
Medical Device Problem Codes	Difficult to Remove (1528); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6) hospital.Initial reporter city: (b)(6).
Event or Problem Description
It was reported that the filterwire was caught in the non-bsc stent and could not be pulled up.The target lesion was located in the internal carotid artery and common carotid artery.A filterwire ez was selected for use.During the procedure, after post dilation, when the filterwire ez retrieval sheath was removed it got caught in a non-bsc stent and could not be pulled up.Another filterwire ez was selected, however, resistance was felt midway, and it could not be advanced.The bent tip was retrieved once and noted a weakening of the tip.Eventually, an extension wire was attached to filterwire ez, then a non-bsc catheter was advanced, and it was able to retrieve successfully.There were no patient complications reported.

• Brand Name: EZ BENT TIP
• Common Device Name: TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15489229
• Report Number: 2124215-2022-36604
• Device Sequence Number: 19322304
• Product Code: NFA
• UDI-Device Identifier: 08714729479109
• UDI-Public: 08714729479109
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2022

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: 09/09/2022
• Device Model Number: 7584
• Device Catalogue Number: 7584
• Device Lot Number: 0025991210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CERULEAN - CATHETER; OPTIMO 8F- GUIDING CATHETER
• Patient Sex: Unknown