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 - CORK ENCORE BALLOON CATHETER INFLATION DEVICE; SYRINGE, BALLOON INFLATION
  • 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 - CORK ENCORE BALLOON CATHETER INFLATION DEVICE; SYRINGE, BALLOON INFLATION Back to Search Results
Model Number H74904526011
Device Problem Incorrect Measurement (1383)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/11/2018
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
 
Event Description
It was reported that the gauge bounced back to zero.A 26 encore balloon catheter inflation device was used with sufficient concomitant connection; however, it was noted that the gauge did not function and bounced back to zero after the fourth inflation.The inflation device failed to inflate after the fourth attempt.The concomitant device appeared inflated even with the gauge bounced back to zero.The procedure was completed with a different device.No reported patient complications and patient is stable.
 
Event Description
It was reported that the gauge bounced back to zero.A 26 encore balloon catheter inflation device was used with sufficient concomitant connection; however, it was noted that the gauge did not function and bounced back to zero after the fourth inflation.The inflation device failed to inflate after the fourth attempt.The concomitant device appeared inflated even with the gauge bounced back to zero.The procedure was completed with a different device.No reported patient complications and patient is stable.
 
Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: the unit was returned.The gauge needle was at 0 atmospheres when received.The device does not have visual defects.A functional test of the complaint device was carried out using a test stopcock.The purpose of this procedure is to ensure that the unit meets the required specification.The device locking mechanism test was performed.This is where the plunger handle is rotated and this test is repeated 20 times consecutively.No issues were noted during the device locking mechanism test.Gauge accuracy test was performed to assess the accuracy of the gauge under pressurization.Side load involved applying a load of 3.5 +/- 0.1 kg to the proximal end of the handle.The unit has passed if the unit maintains a vacuum in this position.The unit passes the test.The unit was primed with 5 ml of water before withdrawing the plunger to create a vacuum.There was no bubble leakage.The unit passed all functional tests without issues.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.  (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENCORE BALLOON CATHETER INFLATION DEVICE
Type of Device
SYRINGE, BALLOON INFLATION
Manufacturer (Section D)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI 
MDR Report Key7491587
MDR Text Key107508538
Report Number2134265-2018-03766
Device Sequence Number1
Product Code MAV
Combination Product (y/n)N
PMA/PMN Number
K955869
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/12/2018
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 Date01/15/2020
Device Model NumberH74904526011
Device Catalogue Number04526-01
Device Lot Number21611520
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2018
Initial Date Manufacturer Received 04/12/2018
Initial Date FDA Received05/07/2018
Supplement Dates Manufacturer Received05/15/2018
Supplement Dates FDA Received06/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-