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

Model Number	29720
Medical Device Problem Codes	Fluid/Blood Leak (1250); Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event date of (b)(4) 2020 is an estimated based of the aware date of (b)(6) 2020 as the exact date was not reported.
Event or Problem Description
It was reported that a crack/break was noted.Vascular access was obtained through the left posterior tibial artery.The target lesion area was located in the popliteal artery.A 1.50mm peripheral rotalink plus was selected for use.Distal rota wire was placed in the left iliac artery.During the procedure, it was noted that the rota catheter was difficult to advance through the popliteal artery although, it ran just fine through the posterior tibial artery and the tibioperoneal trunk.The device was removed and saline/rotaglide spraying out of a crack in the catheter was noticed.Hence, rota catheter had a crack/break at the distal end close to the burr.No patient complications reported.

• 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: 10449158
• Report Number: 2134265-2020-11669
• Device Sequence Number: 3316335
• Product Code: MCW
• UDI-Device Identifier: 08714729838906
• UDI-Public: 08714729838906
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2020

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: 06/15/2022
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0025598849
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 08/25/2020
• 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: GUIDEWIRE-ROTAWIRE; SHEATH-6FR 10CM TERUMO