Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 3243
Device Problem Unsealed Device Packaging (1444)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 10/21/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the packaging seal was torn.A 2.15mm rotapro was selected for use.During preparation, it was found that the packaging seal was torn.There were no patient complications reported.
 
Event Description
It was reported that the packaging seal was torn.A 2.15mm rotapro was selected for use.During preparation, it was found that the packaging seal was torn.There were no patient complications reported.It was further reported that the external packaging seal was torn.
 
Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter state: (b)(6).Device eval by manufacturer: returned product consisted of the rotapro atherectomy system inside the shelf box.The shelf box, closure strip, and product pouch were visually examined.Inspection of the device revealed that the closure strip on the top of the shelf box was peeled back from the shelf box and not secure.The closure strip was also noticed to have been bunched at the end near the arrow.There was evidence of wear marks to the left of the closure strip on the box, which indicates that there was a tight fit and the boxes were rubbing up against each other during either transportation or storage.Product analysis confirmed the reported event, as the top closure strip was peeled back and not adhered to the shelf box.
 
Event Description
It was reported that the packaging seal was torn.A 2.15mm rotapro was selected for use.During preparation, it was found that the packaging seal was torn.There were no patient complications reported.It was further reported that the external packaging seal was torn.
 
Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter state: (b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ROTAPRO
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10809662
MDR Text Key215323557
Report Number2134265-2020-15533
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729893394
UDI-Public08714729893394
Combination Product (y/n)N
PMA/PMN Number
P900056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 12/04/2020
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 Date07/22/2022
Device Model Number3243
Device Catalogue Number3243
Device Lot Number0025754572
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2020
Initial Date Manufacturer Received 10/21/2020
Initial Date FDA Received11/09/2020
Supplement Dates Manufacturer Received11/11/2020
12/02/2020
Supplement Dates FDA Received11/30/2020
12/04/2020
Patient Sequence Number1
-
-