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	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that a fragment of the device remained inside the patient's body.The target lesion was located in the internal carotid artery.A ez bent tip filterwire was selected for use.During procedure, the filterwire was deployed in the distal lesion.Pre-dilatation and stent placement were completed.Angiography was performed and apposition to vessel wall was confirmed.When the filterwire was tried to retrieve using the retrieval sheath, it became caught inside the stent, and it was unable to retrieve.The bent tip device was removed and retrieval was tried to perform, however, it still caught at the same location, and it was unable to retrieve.Dock replacement was done and retrieval was performed using the bent tip device, but still caught at the same location.Repetitive push and pull were done, eventually the filterwire dropped slightly, however the loop remained open.After that, approach was tried to perform using bent tip, but the marker of the bent tip device slipped through the filterwire, and it reached up to m1.The filterwire was removed forcibly while being deployed, and the protruding tip was retrieved.Stent retriever, snare, and aspiration catheter were fully used, but it flowed to m2, and could not be retrieved.The procedure was ended with the fragment left inside the patient's body.No further patient complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6) e1: initial reporter city: (b)(6).
Event or Problem Description
It was reported that a fragment of the device remained inside the patient's body.The target lesion was located in the internal carotid artery.A ez bent tip filterwire was selected for use.During procedure, the filterwire was deployed in the distal lesion.Pre-dilatation and stent placement were completed.Angiography was performed and apposition to vessel wall was confirmed.When the filterwire was tried to retrieve using the retrieval sheath, it became caught inside the stent, and it was unable to retrieve.The bent tip device was removed and retrieval was tried to perform, however, it still caught at the same location, and it was unable to retrieve.Dock replacement was done and retrieval was performed using the bent tip device, but still caught at the same location.Repetitive push and pull were done, eventually the filterwire dropped slightly, however the loop remained open.After that, approach was tried to perform using bent tip, but the marker of the bent tip device slipped through the filterwire, and it reached up to m1.The filterwire was removed forcibly while being deployed, and the protruding tip was retrieved.Stent retriever, snare, and aspiration catheter were fully used, but it flowed to m2, and could not be retrieved.The procedure was ended with the fragment left inside the patient's body.No further patient complications were reported and patient was stable post procedure.It was further reported that the patient had sah (subarachnoid hemorrhage) and after effect has been seen.However, it is unknown whether it was caused by using a snare or the like to retrieve the broken tip.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial reporter city: (b)(6).Device evaluated by mfr: the device was returned for evaluation.The distal section of the retrieval sheath is broken.
Event or Problem Description
It was reported that a fragment of the device remained inside the patient's body.The target lesion was located in the internal carotid artery.A ez bent tip filterwire was selected for use.During procedure, the filterwire was deployed in the distal lesion.Pre-dilatation and stent placement were completed.Angiography was performed and apposition to vessel wall was confirmed.When the filterwire was tried to retrieve using the retrieval sheath, it became caught inside the stent, and it was unable to retrieve.The bent tip device was removed and retrieval was tried to perform, however, it still caught at the same location, and it was unable to retrieve.Dock replacement was done and retrieval was performed using the bent tip device, but still caught at the same location.Repetitive push and pull were done, eventually the filterwire dropped slightly, however the loop remained open.After that, approach was tried to perform using bent tip, but the marker of the bent tip device slipped through the filterwire, and it reached up to m1.The filterwire was removed forcibly while being deployed, and the protruding tip was retrieved.Stent retriever, snare, and aspiration catheter were fully used, but it flowed to m2, and could not be retrieved.The procedure was ended with the fragment left inside the patient's body.No further patient complications were reported and patient was stable post procedure.It was further reported that the patient had sah (subarachnoid hemorrhage) and after effect has been seen.However, it is unknown whether it was caused by using a snare or the like to retrieve the broken tip.

• 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
• MDR Report Key: 9636533
• Report Number: 2134265-2020-00595
• Device Sequence Number: 2784154
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2021
• Device Model Number: 7584
• Device Catalogue Number: 7584
• Device Lot Number: 0023792326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 02/05/2020; 02/28/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 02/21/2020; 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: GUIDE CATHETER USED; GUIDE CATHETER: GUIDE CATHETER USED; LAUNCHER8F; GUIDE CATHETER: GUIDE CATHETER USED
• Outcome Attributed to Adverse Event: Other