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

Model Number	29720
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is an estimated date based off the aware date as the exact event date was not reported.
Event or Problem Description
It was reported that the burr became stuck on the rotawiire.The target area was located in the lower right extremity.A 1.50mm peripheral rotalink plus and a rotawire were selected for use for an atherectomy procedure.The catheter was successfully utilized for the majority of the diseased segment.A touch up for an area was attempted which required reversing the device.However, when the physician attempted to move the burr catheter backwards, the catheter would not track backwards and was stuck on the rotawire.Dynaglide mode was activated, but the burr catheter still would not track on the rotawire.Consequently, the physician had to cut the catheter and removed the catheter and wire together.Rotawire access was lost.There were no patient complications reported and the patient was well.
Additional Manufacturer Narrative
Date of event is an estimated date based off the aware date as the exact event date was not reported.Device evaluated by the manufacturer.The device was returned for analysis.The advancer unit and burr housing were received together.The advancer, handshake connections, sheath, coil and burr were microscopically and visually examined.The sheath is separated/torn 15.5cm from the strain relief and the distal portion of the sheath was not returned.There are numerous sheath kinks along the returned portion of the sheath.The separated coil is stretched and broken on the returned partial rotawire, the coil is separated 128.3cm from the burr tip.The coil and wire were soaked in warm water and the partial wire was able to be removed from the device with restriction due to the stretched coil.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 rotawiire.The target area was located in the lower right extremity.A 1.50mm peripheral rotalink plus and a rotawire were selected for use for an atherectomy procedure.The catheter was successfully utilized for the majority of the diseased segment.A touch up for an area was attempted which required reversing the device.However, when the physician attempted to move the burr catheter backwards, the catheter would not track backwards and was stuck on the rotawire.Dynaglide mode was activated, but the burr catheter still would not track on the rotawire.Consequently, the physician had to cut the catheter and removed the catheter and wire together.Rotawire access was lost.There were no patient complications reported and the patient was well.

• 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: 8735373
• Report Number: 2134265-2019-07443
• Device Sequence Number: 14096533
• Product Code: MCW
• UDI-Device Identifier: 08714729838906
• UDI-Public: 08714729838906
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: 11/18/2020
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0022958396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1