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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC INTRA- AORTIC BALLOOON PRODUCTS

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ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC INTRA- AORTIC BALLOOON PRODUCTS Back to Search Results
Catalog Number IAB-S840C
Device Problems Inflation Problem (1310); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/25/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that while in the cath lab the medical doctor (md) stated that during insertion the balloon was "automatically deflating after inflation. " as a result, the md used another set to complete the procedure successfully. On (b)(6) 2016 additional information was received. 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 the procedure was conducted according to the instruction for use. The procedure was completed successfully after the catheter set was replacement. The second 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
(b)(4). Evaluation: the reported complaint of leak suspected is not confirmed. The device passed functional testing and was pump tested successfully. The root cause of the reported complaint is undetermined. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. Teleflex will continue to monitor for similar reported complaints.
 
Event Description
It was reported that while in the cath lab the medical doctor (md) stated that during insertion the balloon was "automatically deflating after inflation. " as a result, the md used another set to complete the procedure successfully. On 11/01/2016, additional information was received. 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 the procedure was conducted according to the instruction for use. The procedure was completed successfully after the catheter set was replacement. The second 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: 8FR 40CC
Type of DeviceINTRA- AORTIC BALLOOON PRODUCTS
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 Key6123476
MDR Text Key60760708
Report Number1219856-2016-00261
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
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 Received11/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2016
Device Catalogue NumberIAB-S840C
Device Lot Number18F14J0011
Other Device ID Number00801902002679
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2016
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? Yes
Date Device Manufactured09/05/2014
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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