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

Model Number	29720
Medical Device Problem Codes	Entrapment of Device (1212); Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck on the guidewire.The target lesion was located in the tibioperoneal trunk.A 2.00mm peripheral rotalink and peripheral rotawire and wireclip torquer were selected for use.During the procedure, it was noted that the device stalled during advancement.About 75% of the rotablation was completed and the device was being withdrawn in dynaglide mode when the burr became stuck on the wire.The physician had difficulty removing it from the patient's body.The rotalink and rotawire were removed together.The rotablation procedure was completed with this device as the majority of the case was completed.There were multiple areas and the last area was where they had the problem.A new wire was advanced and ballooning completed.There were no patient complications and the patient was fine after the procedure.
Additional Manufacturer Narrative
Device evaluated by the manufacturer.The returned complaint device consisted of a peripheral rotalink burr catheter.The advancer unit was not returned.The entire length of the burr catheter had blood inside of the sheath.The burr catheter was returned with the related rotawire stuck in the device.The handshake connection, sheath, coil, burr and annulus were microscopically and visually examined.The presence of blood indicates that there was not a sufficient flow of saline during the usage of the device.There are numerous sheath kinks.The coil is stretched, and the handshake connection is stuck in the sheath.The device was soaked for a couple days in a warm water bath to in an attempt to remove the rotawire.The returned rotawire was not able to be removed from the device.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the burr became stuck on the guidewire.The target lesion was located in the tibioperoneal trunk.A 2.00mm peripheral rotalink and peripheral rotawire and wireclip torquer were selected for use.During the procedure, it was noted that the device stalled during advancement.About 75% of the rotablation was completed and the device was being withdrawn in dynaglide mode when the burr became stuck on the wire.The physician had difficulty removing it from the patient's body.The rotalink and rotawire were removed together.The rotablation procedure was completed with this device as the majority of the case was completed.There were multiple areas and the last area was where they had the problem.A new wire was advanced and ballooning completed.There were no patient complications and the patient was fine after the procedure.
Event or Problem Description
It was reported that the burr became stuck on the guidewire.The target lesion was located in the tibioperoneal trunk.A 2.00mm peripheral rotalink and peripheral rotawire and wireclip torquer were selected for use.During the procedure, it was noted that the device stalled during advancement.About 75% of the rotablation was completed and the device was being withdrawn in dynaglide mode when the burr became stuck on the wire.The physician had difficulty removing it from the patient's body.The rotalink and rotawire were removed together.The rotablation procedure was completed with this device as the majority of the case was completed.There were multiple areas and the last area was where they had the problem.A new wire was advanced and ballooning completed.There were no patient complications and the patient was fine after the procedure.
Additional Manufacturer Narrative
Device evaluated by the manufacturer.The returned complaint device consisted of a peripheral rotalink burr catheter.The advancer unit was not returned.The entire length of the burr catheter had blood inside of the sheath.The burr catheter was returned with the related rotawire stuck in the device.The handshake connection, sheath, coil, burr and annulus were microscopically and visually examined.The presence of blood indicates that there was not a sufficient flow of saline during the usage of the device.There are numerous sheath kinks.The coil is stretched, and the handshake connection is stuck in the sheath.The device was soaked for a couple days in a warm water bath to in an attempt to remove the rotawire.The returned rotawire was not able to be removed from the device.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 8799136
• Report Number: 2134265-2019-08350
• Device Sequence Number: 10840672
• Product Code: MCW
• UDI-Device Identifier: 08714729838920
• UDI-Public: 08714729838920
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• 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): 09/16/2019

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: 04/24/2021
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0023696259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 07/31/2019; 08/21/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/22/2019; 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1