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

Model Number	3241
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Gas/Air Leak (2946); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the device got separated.The target lesion was located in the severely calcified proximal and middle third of anterior descending artery.A 1.75mm rotalink plus was selected for use.During the procedure, the physician first used a 1.50mm rotalink plus without any problem.Then they requested to use the 1.75mm rotalink plus as either the da vessel was calcified or they just want to exchange to a larger olive size.When a draw test was performed outside the patient, the rotation speed was unstable.When the pedal was activated at the speed of 160,000rpm, it later dropped to 120-110,000rpm sharply.The connectors were checked several times if they were properly in place.However, the physician felt a slight leak in the lower part of the device.Upon withdrawal, the 1.75mm rotalink plus got separated and the physician opted to used only the 1.50mm rotalink plus.No patient complications were reported.
Event or Problem Description
It was reported that the device got separated.The target lesion was located in the severely calcified proximal and middle third of anterior descending artery.A 1.75mm rotalink plus was selected for use.During the procedure, the physician first used a 1.50mm rotalink plus without any problem.Then they requested to use the 1.75mm rotalink plus as either the da vessel was calcified or they just want to exchange to a larger olive size.When a draw test was performed outside the patient, the rotation speed was unstable.When the pedal was activated at the speed of 160,000rpm, it later dropped to 120-110,000rpm sharply.The connectors were checked several times if they were properly in place.However, the physician felt a slight leak in the lower part of the device.Upon withdrawal, the 1.75mm rotalink plus got separated and the physician opted to used only the 1.50mm rotalink plus.No patient complications were reported.
Additional Manufacturer Narrative
E1: initial reporter facility name - (b)(6) hospitalares.Device evaluated by manufacturer: the device was returned for analysis.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found that the advancer handshake connection was bent.During inspection of the remainder of the device, there were no detachments identified.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated.When the rotablator advancer was connected to the rotablator console control system and the foot pedal was pressed, the device stalled and would not run due to the bent handshake connection.The sound of air escaping the device was heard during the stall.Product analysis confirmed the reported rotation issues and air leak, as the handshake connection was bent and caused a device stall; the sound of air escaping the device was heard during the stall.The reported detachment was not able to be confirmed, as there were no detachments noted during inspection of the device.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 13289137
• Report Number: 2134265-2022-00331
• Device Sequence Number: 4409130
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

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: 12/09/2022
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0026603258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2021
• 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
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Race: White