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

Model Number	3241
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the rotawire was stuck with the rotablator.The target lesion was located in the right coronary artery.A 2.00mm rotalink plus and a rotawire were selected for use.During the procedure, after the ablation, the device was trapped near the 7fr non boston scientific guide catheter tip when trying to recover the burr.It was also noted that the device was stuck in the rotawire.Resistance was felt so the devices were removed all together.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of the rotablator rotalink plus atherectomy device.The burr catheter was received attached to the advancer unit.Two non boston scientific guide catheters [one 6f, one 7f] were returned for analysis as well as the rotawire from complaint (b)(4).The burr catheter was received within the 7f guide catheter.The advancer, handshake connections, sheath, coil, burr and annulus were visually examined.Inspection of the device presented no damage or irregularities to the rotablator device.The tip of the non boston scientific guide catheter was found to be damaged.The burr catheter was able to be removed, but with resistance due to the damaged tip.The guide catheters used in the procedure were returned.Functional testing consisted of using the returned guide catheters.The burr was unable to be inserted through the hub of the 6f [0.071 in] guide catheter, and there was severe resistance encountered when attempting to advance the burr through the hub of the 7f [0.081 in] guide catheter.After testing of the burr catheter concluded, the diameter of the burr catheter was measured and found to be within specification.The rotawire used in the procedure was returned.So, functional testing consisted of using the returned rotawire.The wire was inserted into the annulus of the burr and advanced the through the advancer with no resistance or issues.Product analysis did not confirm the reported event, as the test wire was able to be inserted and advanced through the burr catheter with no resistance or issues.The reported difficulty inserting the burr catheter into the guide catheter was confirmed, as the burr catheter was not able to be inserted into the returned 6f guide catheter and severe resistance was encountered during testing of the 7f guide catheter.
Event or Problem Description
It was reported that the rotawire was stuck with the rotablator.The target lesion was located in the right coronary artery.A 2.00mm rotalink plus and a rotawire were selected for use.During the procedure, after the ablation, the device was trapped near the 7fr non boston scientific guide catheter tip when trying to recover the burr.It was also noted that the device was stuck in the rotawire.Resistance was felt so the devices were removed all together.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: ROTALINK PLUS
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13253312
• Report Number: 2134265-2022-00067
• Device Sequence Number: 4520979
• Product Code: MCX
• UDI-Device Identifier: 08714729316442
• UDI-Public: 08714729316442
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022

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: 06/09/2023
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0027636705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2021
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER - 7FR JR3.5 LAUNCHER; GUIDE CATHETER - 7FR JR3.5 LAUNCHER
• Patient Sex: Unknown