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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 BALLOON

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ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC INTRA-AORTIC BALLOON Back to Search Results
Catalog Number IAB-S840C
Device Problem Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/10/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of "the driveline tubing would not properly fit into the receiving port of the maquet iabp machine/console" is not able to be confirmed. The root cause of the complaint is undetermined. 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. The reported complaint will be monitored for any developing trends. If the product is returned at a later date, a full investigation of the sample will be completed. No further action required at this time. Other remarks: for related complaint see mdr #1219856-2017-00310 and (b)(4).
 
Event Description
It was reported that during the procedure a 40 cc intra-aortic balloon (iab) was inserted. While connecting the iab driveline tubing into the port of the competitors pump, the driveline tubing would not properly fit into the receiving port of the competitors machine/console. As a result, the iab was removed and replaced. There was no reported patient death or serious injury. There was a delay or interruption in therapy that caused no harm to the patient. There were no patient complications.
 
Manufacturer Narrative
(b)(4). Other remarks: for related complaint see mdr #1219856-2017-00310 and (b)(4).
 
Event Description
It was reported that during the procedure a 40 cc intra-aortic balloon (iab) was inserted. While connecting the iab driveline tubing into the port of the competitors pump, the driveline tubing would not properly fit into the receiving port of the competitors machine/console. As a result, the iab was removed and replaced. There was no reported patient death or serious injury. There was a delay or interruption in therapy that caused no harm to the patient. There were no patient complications.
 
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Brand NameREDIGUARD IAB: 8FR 40CC
Type of DeviceINTRA-AORTIC BALLOON
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key7138884
MDR Text Key265390701
Report Number1219856-2017-00311
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIN
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 11/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Catalogue NumberIAB-S840C
Device Lot Number18F17C0060
Other Device ID Number00801902002679
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2017
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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