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	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.Initial reporter name and address: (b)(6).
Event or Problem Description
It was reported that the rotaglide was contaminated.A rotablator rotaglide lubricant was selected for use.During routine check, it was noted that a black sediment was seen in the device lubricant.However, there was no issue with the vial.The case did not proceed.
Event or Problem Description
It was reported that the rotaglide was contaminated.A rotablator rotaglide lubricant was selected for use.During routine check, it was noted that a black sediment was seen in the device lubricant.However, there was no issue with the vial.The case did not proceed.
Additional Manufacturer Narrative
B3 date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.E1: initial reporter address 1 - (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The complaint sample we received was already broached.Approximately half of the initial volume was left in the vial.A small dark particle was visible on the bottom of the vial.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.

• Brand Name: ROTABLATOR ROTAGLIDE LUBRICANT
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): FRESENIUS KABI AUSTRIA GMBH; hafnerstrasse 36; graz 8055 ; AU 8055
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12749246
• Report Number: 2134265-2021-13279
• Device Sequence Number: 17305217
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2021

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: 10/21/2022
• Device Model Number: 3779
• Device Catalogue Number: 3779
• Device Lot Number: PP1943022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2019
• 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 Sex: Unknown