MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number	3600
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.Procedure summary: the 85% stenosed target lesion was in the middle to proximal right coronary artery (rca).The lesion was 3mm in length and 3mm in vessel diameter.The lesion anatomy was not tortuous.There was a significantly greater than 45 and less than 90 degree bend in the lesion with moderate calcification.Vascular access was gained via a right femoral artery.A rotapro 1.50mm and a rotawire were selected for treatment.During preparation the rotawire became stuck within the rotapro advancer handle.By activating dynaglide mode resistance was lowered and rotawire was fully inserted.The rotapro 1.50mm and a rotawire were positioned close to the guide catheter tip in the proximal rca.Ablation was attempted but failed to reach optimum speed.The device stalled.Switched the system to dynaglide mode and then back to restart ablation.The device stalled.Guide catheter and rotapro 1.50mm position was changed several times to get optimal alignment with the vessel.The device stalled.The rotapro 1.50mm was retracted in dynaglide mode and experienced strong resistance from rotawire.The whole system was retracted and exchanged for a second rotawire and rotapro catheter.The procedure was continued without further issues and ended successfully.No patient harm resulted in relation to this event.The patient was stable post procedure.
Additional Manufacturer Narrative
Additional information to section d.Suspect medial device information was updated for the lot number and brand name.
Event or Problem Description
It was reported that device entrapment occurred.Procedure summary: the 85% stenosed target lesion was in the middle to proximal right coronary artery (rca).The lesion was 3mm in length and 3mm in vessel diameter.The lesion anatomy was not tortuous.There was a significantly greater than 45 and less than 90 degree bend in the lesion with moderate calcification.Vascular access was gained via a right femoral artery.A rotapro 1.50mm and a rotawire were selected for treatment.During preparation the rotawire became stuck within the rotapro advancer handle.By activating dynaglide mode resistance was lowered and rotawire was fully inserted.The rotapro 1.50mm and a rotawire were positioned close to the guide catheter tip in the proximal rca.Ablation was attempted but failed to reach optimum speed.The device stalled.Switched the system to dynaglide mode and then back to restart ablation.The device stalled.Guide catheter and rotapro 1.50mm position was changed several times to get optimal alignment with the vessel.The device stalled.The rotapro 1.50mm was retracted in dynaglide mode and experienced strong resistance from rotawire.The whole system was retracted and exchanged for a second rotawire and rotapro catheter.The procedure was continued without further issues and ended successfully.No patient harm resulted in relation to this event.The patient was stable post procedure.It was further reported that the target rotational speed was 160000 rpm and the speed observed was between 130000 to 140000 rpm.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of the rotawire.The rotapro used in the procedure was returned with the returned rotawire within the returned rotapro device.The proximal end, middle section, distal end, and spring tip were visually and microscopically examined.Inspection of the device found a kink at 101cm from the distal end of the rotawire.Functional testing was performed using the returned rotawire.During testing, the returned rotawire was able to be removed with resistance.It was not able to be fully reinserted due to the kink in the rotawire.Product analysis is consistent with the reported events, as the returned rotawire was able to be removed with resistance but was not able to be reinserted due to the kink in the rotawire.
Event or Problem Description
It was reported that device entrapment occurred.Procedure summary: the 85% stenosed target lesion was in the middle to proximal right coronary artery (rca).The lesion was 3mm in length and 3mm in vessel diameter.The lesion anatomy was not tortuous.There was a significantly greater than 45 and less than 90 degree bend in the lesion with moderate calcification.Vascular access was gained via a right femoral artery.A rotapro 1.50mm and a rotawire were selected for treatment.During preparation the rotawire became stuck within the rotapro advancer handle.By activating dynaglide mode resistance was lowered and rotawire was fully inserted.The rotapro 1.50mm and a rotawire were positioned close to the guide catheter tip in the proximal rca.Ablation was attempted but failed to reach optimum speed.The device stalled.Switched the system to dynaglide mode and then back to restart ablation.The device stalled.Guide catheter and rotapro 1.50mm position was changed several times to get optimal alignment with the vessel.The device stalled.The rotapro 1.50mm was retracted in dynaglide mode and experienced strong resistance from rotawire.The whole system was retracted and exchanged for a second rotawire and rotapro catheter.The procedure was continued without further issues and ended successfully.No patient harm resulted in relation to this event.The patient was stable post procedure.It was further reported that the target rotational speed was 160000 rpm and the speed observed was between 130000 to 140000 rpm.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15939408
• Report Number: 2124215-2022-51301
• Device Sequence Number: 20419626
• Product Code: MCX
• UDI-Device Identifier: 08714729195573
• UDI-Public: 08714729195573
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P900056
• 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,Followup,Followup
• Report Date (Section B): 02/13/2023

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: 12/02/2023
• Device Model Number: 3600
• Device Catalogue Number: 3600
• Device Lot Number: 0028488609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 12/07/2022; 01/26/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 12/08/2022; 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• 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
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 76 KG