MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number	3241
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the device was stuck in the lesion.The target lesion was located in the severely calcified proximal right coronary artery.A 2.00mm rotalink plus was selected for use.During procedure, after ablation was performed by a 1.5mm burr, the size was increased to 2.00mm.However, the burr got stuck upon crossing the lesion and was successfully removed by deeply engaging the guiding.The procedure was completed with this device.There were no patient complications reported.
Additional Manufacturer Narrative
E1.Initial reporter city: (b)(6).
Event or Problem Description
It was reported that the device was stuck in the lesion.The target lesion was located in the severely calcified proximal right coronary artery.A 2.00mm rotalink plus was selected for use.During procedure, after ablation was performed by a 1.5mm burr, the size was increased to 2.00mm.However, the burr got stuck upon crossing the lesion and was successfully removed by deeply engaging the guiding.The procedure was completed with this device.There were no patient complications reported.It was further reported that the burr was stuck in a 100% stenosed, moderately tortuous, and severely calcified lesion.The patient was good post procedure.
Additional Manufacturer Narrative
E1.Initial reporter city: (b)(6).Device evaluated by manufacturer.The device was returned for analysis.The returned complaint device consisted of a rotablator plus device.The burr catheter was received attached to the advancer unit.The returned rotawire was received inside of the device.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically exanimated.The rotawire was able to be removed from the device.Microscopic examination of the device revealed that the annulus was damaged and not round which is consistent with damage seen with the use of a rotawire.The coil has become stretched due to manipulation during the procedure.Functional testing was performed by attempting to rotate the drive shaft, however, it was unable to rotate.Product analysis confirmed the reported event due to the melted ultem.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported event.
Event or Problem Description
It was reported that the device was stuck in the lesion.The target lesion was located in the severely calcified proximal right coronary artery.A 2.00mm rotalink plus was selected for use.During procedure, after ablation was performed by a 1.5mm burr, the size was increased to 2.00mm.However, the burr got stuck upon crossing the lesion and was successfully removed by deeply engaging the guiding.The procedure was completed with this device.There were no patient complications reported.It was further reported that the burr was stuck in a 100% stenosed, moderately tortuous, and severely calcified lesion.The patient was good post procedure.

• Brand Name: ROTALINK PLUS
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10224372
• Report Number: 2134265-2020-08795
• Device Sequence Number: 19631984
• Product Code: MCX
• UDI-Device Identifier: 08714729316442
• UDI-Public: 08714729316442
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2020

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: 07/28/2021
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0024340921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 07/14/2020; 08/03/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 07/27/2020; 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1