• 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 - MAPLE GROVE NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

  • 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 - MAPLE GROVE NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493926720350
Device Problem Device Packaging Compromised (2916)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a nc emerge catheter in its original packaging with the closure strip intact. The shelf box was received closed with the closure strip intact. The corners, sides, top, and back of the shelf box were crushed/damaged. The product pouch and catheter were removed from the shelf box and checked for damage. There was corresponding damage to the product pouch, there was no damage to the device inside of the pouch. Inspection of the remainder of the packaging and device, apart from the observed damage, revealed no other damage or irregularities. No other issues were identified during the product analysis. The most probable root cause is considered handling damage as the event occurred without direct patient contact. (b)(4).
 
Event Description
Reportable based on device analysis completed on 15-sep-2017. It was reported that packaging damage occurred. A 3. 50mm x 20mm nc emerge® balloon catheter's packaging was damaged upon arrival. However, returned device analysis revealed that the inner pouch was also damaged, therefore sterility of device was compromised.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNC EMERGE®
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6908880
MDR Text Key89465983
Report Number2134265-2017-09733
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/29/2019
Device Model NumberH7493926720350
Device Catalogue Number39267-2035
Device Lot Number20830994
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-