• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC

  • 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
 

ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-05840-LWS
Device Problem Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/27/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint that "the blue connector was broken" is confirmed. The gray fos connector was returned with a missing retaining tab and was fully separated from the blue slide housing. Therefore, an fos connection was unable to be established. Although, the root cause of the recessed fos is undetermined this type of damage can occur if the fos connector recesses and the retaining tabs on the gray fos connector break. A device history record (dhr) review was conducted for the lot number with no relevant findings. The device passed all manufacturing specifications prior to release. Teleflex assessed the risk for the reported complaint. There are no new or revised risks. This issue will be monitored for any developing trends. A nonconformance has been initiated to further investigate the cause.
 
Event Description
It was reported that during insertion while the balloon was being placed into the patient, they noticed that the blue connector was broken. As a result, the device was removed and replaced by another unit. There was no reported patient death, injury or complications. It is unknown if there was a delay/interruption in therapy and if medi cal/surgical intervention was required.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during insertion while the balloon was being placed into the patient, they noticed that the blue connector was broken. As a result, the device was removed and replaced by another unit. There was no reported patient death, injury or complications. It is unknown if there was a delay/interruption in therapy and if medical/surgical intervention was required.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key6820368
MDR Text Key246437638
Report Number1219856-2017-00186
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F17C0043
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/16/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-