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

Model Number	H749236310020
Medical Device Problem Codes	Entrapment of Device (1212); Nonstandard Device (1420); Difficult to Remove (1528); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E! initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the burr became stuck with the rotawire.The target lesion was located in the anterior descending branch.A 1.25mm rotablator rotalink plus and a rotawire were selected for used.During the procedure, upon in vitro test, the speed was set to 148,000 rpm and a 144,000 maximum speed was observed.During advancement, significant resistance was felt, and the device could not be advanced.It was noted that the burr and the rotawire became stuck together and a stall was indicated.The burr was unable to be advanced into the lesion site and could not be withdrawn even after switching between high and low speeds.The rotawire and the entire delivery system of the burr were pulled out together from the patient.The procedure was completed with another of the same device.The patient condition was stable post procedure.
Event or Problem Description
It was reported that the burr became stuck with the rotawire.The target lesion was located in the anterior descending branch.A 1.25mm rotablator rotalink plus and a rotawire were selected for used.During the procedure, upon in vitro test, the speed was set to 148,000 rpm and a 144,000 maximum speed was observed.During advancement, significant resistance was felt, and the device could not be advanced.It was noted that the burr and the rotawire became stuck together and a stall was indicated.The burr was unable to be advanced into the lesion site and could not be withdrawn even after switching between high and low speeds.The rotawire and the entire delivery system of the burr were pulled out together from the patient.The procedure was completed with another of the same device.The patient condition was stable post procedure.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6) device evaluated by manufacturer: the burr catheter was received attached to the advancer unit for analysis.Visual inspection identified no damages or defects.Majority of the returned wire exited the advancer and was not visible at the burr end of the device indicating that there was a wire separation.The wire was removed from the advancer distally without issue after dismantling the handshake connection between the advancer and the burr catheter.The wire was then removed from the burr catheter proximally without issue or resistance.No floppy end of the wire was returned with the complaint device.After destructive testing was performed, it was found that the drive shaft (turbine) was corroded, indicating the presence of dried saline within the device.A detailed microscopic examination of the device found no damage or irregularity.When the rotablator plus system was connected to the rotablator console and the foot pedal was pushed, the device stalled and would not run.In order to determine the cause for the device stall, destructive testing was performed, in which the advancer was dismantled.
Additional Manufacturer Narrative
E1.Updated zipcode, e1 initial reporter phone: (b)(6).Device evaluated by manufacturer: the burr catheter was received attached to the advancer unit for analysis.Visual inspection identified no damages or defects.Majority of the returned wire exited the advancer and was not visible at the burr end of the device indicating that there was a wire separation.The wire was removed from the advancer distally without issue after dismantling the handshake connection between the advancer and the burr catheter.The wire was then removed from the burr catheter proximally without issue or resistance.No floppy end of the wire was returned with the complaint device.After destructive testing was performed, it was found that the drive shaft (turbine) was corroded, indicating the presence of dried saline within the device.A detailed microscopic examination of the device found no damage or irregularity.When the rotablator plus system was connected to the rotablator console and the foot pedal was pushed, the device stalled and would not run.In order to determine the cause for the device stall, destructive testing was performed, in which the advancer was dismantled.
Event or Problem Description
It was reported that the burr became stuck with the rotawire.The target lesion was located in the anterior descending branch.A 1.25mm rotablator rotalink plus and a rotawire were selected for used.During the procedure, upon in vitro test, the speed was set to 148,000 rpm and a 144,000 maximum speed was observed.During advancement, significant resistance was felt, and the device could not be advanced.It was noted that the burr and the rotawire became stuck together and a stall was indicated.The burr was unable to be advanced into the lesion site and could not be withdrawn even after switching between high and low speeds.The rotawire and the entire delivery system of the burr were pulled out together from the patient.The procedure was completed with another of the same device.The patient condition was stable post procedure.

• Brand Name: ROTALINK? PLUS
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22233361
• Report Number: 2124215-2025-37762
• Device Sequence Number: 8186066
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: (01)08714729316411(17)261222(10)35672100
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 12/19/2025

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 Model Number: H749236310020
• Device Catalogue Number: H749236310020
• Device Lot Number: 0035672100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 07/18/2025; 11/25/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 08/12/2025; 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2025
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 80 KG