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	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr was stuck with the guidewire.The chronic totally occluded target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 1.50mm, 1.25mm rotalink burr and two rotawires were selected for use.During the procedure, the first rotawire was crossed and the physician prepared a 1.5x12mm non-boston scientific balloon for pre-dilation, but failed to cross.A 7f non-boston scientific guide catheter was replaced and the guidewire was exchange to a grinding guidewire through the microcatheter.An in vitro test was performed and after that, the physician delivered the burr through the y-valve and used a low speed for easier delivering, at which point it failed to push and indicated a stall.After stopping the rotation speed and retracting, it was found that the burr was holding with the guidewire and could not be withdrawn from the burr alone.Then, the operator chose to withdraw the abrasive head together with the guidewire but still could not withdrawn.The burr was inside the guiding at the time of the incident and the physician then replaced the guide wire and burr, but the same problem occurred.The procedure was completed with a different device.No complications were reported, and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The proximal end, middle section, distal end, and spring tip were visually and microscopically examined.Inspection of the device found a kink at 135cm from the proximal end of the rotawire.Functional testing was performed using the returned rotawire.During testing, the returned rotawire was able to be removed with resistance but was not able to be reinserted due to the kink in the rotawire.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the burr was stuck with the guidewire.The chronic totally occluded target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 1.50mm, 1.25mm rotalink burr and two rotawires were selected for use.During the procedure, the first rotawire was crossed and the physician prepared a 1.5x12mm non-boston scientific balloon for pre-dilation, but failed to cross.A 7f non-boston scientific guide catheter was replaced and the guidewire was exchange to a grinding guidewire through the microcatheter.An in vitro test was performed and after that, the physician delivered the burr through the y-valve and used a low speed for easier delivering, at which point it failed to push and indicated a stall.After stopping the rotation speed and retracting, it was found that the burr was holding with the guidewire and could not be withdrawn from the burr alone.Then, the operator chose to withdraw the abrasive head together with the guidewire but still could not withdrawn.The burr was inside the guiding at the time of the incident and the physician then replaced the guide wire and burr, but the same problem occurred.The procedure was completed with a different device.No complications were reported, and the patient's status was stable.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16707179
• Report Number: 2124215-2023-16003
• Device Sequence Number: 17051196
• Product Code: MCX
• UDI-Device Identifier: 08714729195573
• UDI-Public: 08714729195573
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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: 10/03/2024
• Device Model Number: 3600
• Device Catalogue Number: 3600
• Device Lot Number: 0030275377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 55 KG