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

Model Number	29720
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight: 47.3kg.
Event or Problem Description
It was reported that the rotawire and burr became twisted resulting in a rotawire separation.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified pulmonary artery (pa).First, ablation was performed using 1.5mm burr in the proximal pa.Treatment was then continued in the distal pa to proximal part using 3.0x210mm non bsc balloon catheter.The lesion was not fully dilated so a 2.5x20mm non bsc balloon catheter was used.The 1.5mm burr was then exchanged to a 1.25mm burr.It was noted the rotawire became trapped in the calcification of the artery and the rotawire became twisted when the burr was rotating.Rotawire separation occurred.There were two separated parts found in distal pa.Part of the separated wire was successfully in the proximal part using a snare.The other detached piece was unable to be retrieve, so it remained as it was.The procedure was completed with another of the same device.No further patient complications were reported.
Event or Problem Description
It was reported that the rotawire and burr became twisted resulting in a rotawire separation.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified pulmonary artery (pa).First, ablation was performed using 1.5mm burr in the proximal pa.Treatment was then continued in the distal pa to proximal part using 3.0x210mm non bsc balloon catheter.The lesion was not fully dilated so a 2.5x20mm non bsc balloon catheter was used.The 1.5mm burr was then exchanged to a 1.25mm burr.It was noted the rotawire became trapped in the calcification of the artery and the rotawire became twisted when the burr was rotating.Rotawire separation occurred.There were two separated parts found in distal pa.Part of the separated wire was successfully in the proximal part using a snare.The other detached piece was unable to be retrieve, so it remained as it was.The procedure was completed with another of the same device.No further patient complications were reported.It was further reported that the device was pulled out from the patient's body and there were no visible issue/damaged noted on the burr.The patient was stable after the procedure.
Additional Manufacturer Narrative
Patient weight: 47.3kg.Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connections, sheath, coil, burr and annulus were microscopically and visually examined.Microscopic examination of the device revealed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire.The coil is damaged inside of the burr.The coil is stretched.Functional testing was performed using a test rotawire.The test rotawire was attempted to be inserted into the burr tip and would not pass the damaged coils inside of the burr.The test wire was then inserted into the proximal end of the rotablator burr device and it advanced all the way through the device stopping at the damaged burr.Inspection of the remainder of the device presented no other damage or irregularities.
Additional Manufacturer Narrative
A4.Weight: 47.3kg.
Event or Problem Description
It was reported that the rotawire and burr became twisted resulting in a rotawire separation.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified pulmonary artery (pa).First, ablation was performed using 1.5mm burr in the proximal pa.Treatment was then continued in the distal pa to proximal part using 3.0x210mm non bsc balloon catheter.The lesion was not fully dilated so a 2.5x20mm non bsc balloon catheter was used.The 1.5mm burr was then exchanged to a 1.25mm burr.It was noted the rotawire became trapped in the calcification of the artery and the rotawire became twisted when the burr was rotating.Rotawire separation occurred.There were two separated parts found in distal pa.Part of the separated wire was successfully in the proximal part using a snare.The other detached piece was unable to be retrieve, so it remained as it was.The procedure was completed with another of the same device.No further patient complications were reported.It was further reported that the device was pulled out from the patient's body and there were no visible issue/damaged noted on the burr.The patient was stable after the procedure.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9119323
• Report Number: 2134265-2019-11606
• Device Sequence Number: 2347037
• Product Code: MCW
• UDI-Device Identifier: 08714729857808
• UDI-Public: 08714729857808
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121774
• 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): 11/15/2019

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: 04/18/2020
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0022012785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 09/26/2019; 10/27/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 10/08/2019; 11/15/2019
• 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: BALLOON CATHETER- 2.5/20MM NSE; BALLOON CATHETER- 2.5/20MM NSE; BALLOON CATHETER- 2.5/20MM NSE; BALLOON CATHETER- 3.0/210MM RAPIDCROSS; BALLOON CATHETER- 3.0/210MM RAPIDCROSS; BALLOON CATHETER- 3.0/210MM RAPIDCROSS; BALLOON CATHETER- 2.5/20MM NSE; BALLOON CATHETER- 3.0/210MM RAPIDCROSS