MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTAGLIDE LUBRICANT; CATHETER, CORONARY, ATHERECTOMY

Model Number	3779
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the solution has foreign substance.A rotablator rotaglide lubricant was selected for use.During preparation, it was noted that the lubricant solution has a foreign substance.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the complaint device was received for analysis by the sfmd.The complaint sample received was already broached.Approximately half of the initial volume was left in the vial.A small dark particle was visible on the surface of the emulsion.The particle was isolated by filtering the emulsion through a filter.The isolated particle was microscopically evaluated and clearly proven to be a stopper-fragment, which has been poked out of the stopper when it was pierced.Stopper-coring is unfortunately an issue, which cannot be completely avoided, and which is not related to the quality of the product.A substance was found in the lubricant solution, however, it was determined to be a fragment of the device stopper, and not foreign matter.It has been comprehensibly evaluated that stopper coring during the application led to the occurrence of stopper fragmentation.
Event or Problem Description
It was reported that rotaglide solution has foreign substance.A rotablator rotaglide lubricant was selected for use.During preparation it was noted that the lubricant solution has a foreign substance.The procedure was completed with another of same device.No patient complications were reported.

• Brand Name: ROTABLATOR ROTAGLIDE LUBRICANT
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12239906
• Report Number: 2134265-2021-09632
• Device Sequence Number: 4101112
• Product Code: MCX
• UDI-Device Identifier: 08714729837619
• UDI-Public: 08714729837619
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2021

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: 01/21/2022
• Device Model Number: 3779
• Device Catalogue Number: 3779
• Device Lot Number: PP1904001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1