• 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 H7493926712300
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 08/09/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter. The balloon was loosely folded. The outer shaft, inner shaft, balloon and tip were microscopically examined. There is tip damage. The hypotube shaft was completely separated 41. 5cm from the hub. The fracture faces were oval as if kinked prior to separation. There was no evidence of any material or manufacturing deficiencies contributing to the damage. There were numerous hypotube and shaft kinks. Reviews of documentation to ensure that all required in-process and final inspections and testing were completed and all acceptance criteria were met. There is no evidence that the device failed to meet applicable product specifications prior to shipment. The most probable root cause is operational context as device performance was limited due to anatomical procedural factors. (b)(4).
 
Event Description
It was reported that shaft break occurred. During preparation of a 3. 00mm x 12mm nc emerge balloon catheter, when the physician pulled the device out of the hoop, the catheter separated at the connection between the hypotube and distal catheter bond. The device never entered the patient's body and the procedure was completed with another of the same device. No patient complications were reported.
 
Manufacturer Narrative
(b)(4). Device evaluated by mfr. : the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.   (b)(4).
 
Event Description
It was reported that shaft break occurred. During preparation of a 3. 00mm x 12mm nc emerge® balloon catheter, when the physician pulled the device out of the hoop, the catheter separated at the connection between the hypotube and distal catheter bond. The device never entered the patient's body and the procedure was completed with another of the same device. No patient complications were reported.
 
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 Key6835949
MDR Text Key246656224
Report Number2134265-2017-08773
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,Followup
Report Date 08/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/25/2019
Device Model NumberH7493926712300
Device Catalogue Number39267-1230
Device Lot Number20927186
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-