• 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 INTRA- AORTIC BALLOON FIBER OPTIC

  • 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 INTRA- AORTIC BALLOON FIBER OPTIC Back to Search Results
Catalog Number IAB-05840-LWS
Device Problem Fluid Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/04/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was been reported that while in the cath lab the intra-aortic balloon catheter (iab) was prepped per instruction. The iab was inserted and the patient was sent to surgery. At this time the rn stated that the iab ruptured and was removed. A new iab was retrieved and inserted without difficulty. There was no reported death, injury or harm to the patient. There was a "mild delay" in iabp therapy for the time frame required to prep the new iab and they also brought a second pump into the or for use.
 
Manufacturer Narrative
(b)(4). No product was returned for evaluation. The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for all the lot numbers at this account with no relevant findings. All devices passed all manufacturing specifications prior to release. Conclusion: the reported complaint of blood in helium pathway is not able to be confirmed. No product was returned for evaluation. The root cause of the complaint is undetermined. If the sample is returned at a later date, a full investigation will be completed.
 
Event Description
It was been reported that while in the cath lab the intra-aortic balloon catheter (iab) was prepped per instruction. The iab was inserted and the patient was sent to surgery. At this time the rn stated that the iab ruptured and was removed. A new iab was retrieved and inserted without difficulty. There was no reported death, injury or harm to the patient. There was a "mild delay" in iabp therapy for the time frame required to prep the new iab and they also brought a second pump into the or for use.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of DeviceINTRA- AORTIC BALLOON FIBER OPTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key5990257
MDR Text Key56030051
Report Number1219856-2016-00213
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021462
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 09/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAB-05840-LWS
Device Lot NumberN/A
Other Device ID Number00801902007247
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-