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

Model Number 3779

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2021

Event Type  malfunction  

Event 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.

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 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
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12239906
• MDR Text Key: 263889539
• Report Number: 2134265-2021-09632
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729837619
• UDI-Public: 08714729837619
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1