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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC INTRA-AORTIC BALLOON

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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 Known Impact Or Consequence To Patient (2692)
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 inflating well. As a result the medical doctor (md) used another set to complete the procedure successfully. Additional information received on (b)(6) 2016: the 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 md noticed that the balloon was automatically deflated after inflation. The md removed the failed catheter with sheath together and all the procedure was conducted according to the instruction for use. The procedure was completed successfully after the catheter set was replaced. The second intra-aortic balloon (iab) was inserted via a super-arrow flex sheath into the same insertion site. The length of time prior to the event is 15 minutes. There was a 10 minute delay / interruption in therapy. There was no harmful outcome to the patient.
 
Manufacturer Narrative
Qn#(b)(4). Evaluation: the product was not returned for to teleflex for evaluation, therefore, we cannot confirm the reported complaint that the balloon would not inflate properly. 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. We will continue to monitor for this reported complaint.
 
Event Description
It was reported that while in the cath lab the medical doctor (md) stated that the balloon was not inflating well. As a result the medical doctor(md)used another set to complete the procedure successfully. Additional information received on 11/1/16: the 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 md noticed that the balloon was automatically deflated after inflation. The md removed the failed catheter with sheath together and all the procedure was conducted according to the instruction for use. The procedure was completed successfully after the catheter set was replaced. The second intra-aortic balloon (iab) was inserted via a super-arrow flex sheath into the same insertion site. The length of time prior to the event is 15 minutes. There was a 10 minute delay / interruption in therapy. There was no harmful outcome to the patient.
 
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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 Key6124000
MDR Text Key60752144
Report Number1219856-2016-00270
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 distributor,foreign,health pr
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/24/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2016
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

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