• 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. REDIGUARD IAB: 7FR 30CC INTRA-AORTIC BALLOON

  • 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. REDIGUARD IAB: 7FR 30CC INTRA-AORTIC BALLOON Back to Search Results
Catalog Number IAB-S730C
Device Problem Inflation Problem (1310)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/06/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Sample was discarded.
 
Event Description
It was reported that while in the cath lab the medical doctor (md) stated that the balloon was not fully inflated. As a result the medical doctor (md) used another set to complete the procedure successfully. Additional information received on 11/1/16: the medical doctor (md) properly maintained the vacuum on the balloon and there was nothing special at that time. During the intra-aortic balloon pump (iabp) therapy, the medical doctor (md) noticed that the balloon was automatically deflated after inflation. The medical doctor (md) removed the failed catheter with sheath together and all of the procedure was conducted according to the instruction for use. The procedure was completed successfully after the catheter set replacement. The second intra-aortic balloon (iab) was inserted via a super-arrow flex sheath into the same insertion site. There was no delay or interruption in therapy. There was no reported patient death, injury or complications. There was no harmful outcome to the patient.
 
Manufacturer Narrative
(b)(4). The product was not returned for evaluation. 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. Conclusion: the reported complaint that the balloon would not inflate properly is not able to be confirmed. The product was not returned for evaluation. The root cause of the complaint is undetermined.
 
Event Description
It was reported that while in the cath lab the medical doctor (md) stated that the balloon was not fully inflated. As a result the medical doctor (md) used another set to complete the procedure successfully. Additional information received on 11/1/16: the medical doctor (md) properly maintained the vacuum on the balloon and there was nothing special at that time. During the intra-aortic balloon pump (iabp) therapy, the medical doctor (md) noticed that the balloon was automatically deflated after inflation. The medical doctor (md) removed the failed catheter with sheath together and all of the procedure was conducted according to the instruction for use. The procedure was completed successfully after the catheter set replacement. The second intra-aortic balloon (iab) was inserted via a super-arrow flex sheath into the same insertion site. There was no delay or interruption in therapy. There was no reported patient death, injury or complications. There was no harmful outcome to the patient.
 
Manufacturer Narrative
(b)(4). Date was reported incorrect and corrected.
 
Event Description
It was reported that while in the cath lab the medical doctor (md) stated that the balloon was not fully inflated. As a result the medical doctor (md) used another set to complete the procedure successfully. Additional information received on 11/1/2016: the medical doctor (md) properly maintained the vacuum on the balloon and there was nothing special at that time. During the intra-aortic balloon pump (iabp) therapy, the medical doctor (md) noticed that the balloon was automatically deflated after inflation. The medical doctor (md) removed the failed catheter with sheath together and all of the procedure was conducted according to the instruction for use. The procedure was completed successfully after the catheter set replacement. The second intra-aortic balloon (iab) was inserted via a super-arrow flex sheath into the same insertion site. There was no delay or interruption in therapy. There was no reported patient death, injury or complications. There was no harmful outcome to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREDIGUARD IAB: 7FR 30CC
Type of DeviceINTRA-AORTIC BALLOON
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 Key6123356
MDR Text Key60866941
Report Number1219856-2016-00271
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K981660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 10/24/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2016
Device Catalogue NumberIAB-S730C
Device Lot Number18F14H0011
Other Device ID Number00801902002686
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 Received12/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/05/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-