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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the device became stuck on the wire.A 1.25mm peripheral rotalink plus and a peripheral rotawire guidewire were selected for use in an atherectomy procedure.After atherectomy was completed, it was noted that the device adhered to the rotawire.The devices were removed through the 5fr sheath.The procedure was completed.No complications were reported, and the patient had good results.
Event or Problem Description
It was reported that the device became stuck on the wire.A 1.25mm peripheral rotalink plus and a peripheral rotawire guidewire were selected for use in an atherectomy procedure.After atherectomy was completed, it was noted that the device adhered to the rotawire.The devices were removed through the 5fr sheath.The procedure was completed.No complications were reported, and the patient had good results.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr: the device was returned for analysis.The burr catheter was received attached to the advancer unit with the rotawire separated from the device.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection found no damage or defect with the returned device.The rotawire returned with the complaint device was used to test with the rotalink device.The wire was inserted into the burr and advanced through the device and out of the proximal end.The wire advanced easily and without issue.No issues were identified during the product analysis.

• 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: 11329977
• Report Number: 2134265-2021-01719
• Device Sequence Number: 11040825
• Product Code: MCW
• UDI-Device Identifier: 08714729857808
• UDI-Public: 08714729857808
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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: 11/03/2022
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0026294848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1