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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 9FR 50CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. REDIGUARD IAB: 9FR 50CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-R950-U
Device Problems Device Alarm System (1012); Material Rupture (1546)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 01/03/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the intra-aortic balloon (iab) was inserted in the left axilla, and the iab ruptured the same day. As a result, the iab was removed, but a surgical cut down was required. There was no report of patient death.
 
Manufacturer Narrative
(b)(4). Teleflex did not received the device for investigation therefore the reported complaint of "blood in helium pathway" is not able to be confirmed. The root cause of the complaint is undetermined. If the product is returned at a later date, a full investigation of the sample will be completed. The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings. All devices passed manufacturing specifications prior to release. Teleflex assessed the risk for the reported complaint. There are no new or revised risks. The reported complaint will be monitored for any developing trends. No further action required at this time.
 
Event Description
It was reported the intra-aortic balloon (iab) was inserted in the left axilla, and the iab ruptured the same day. As a result, the iab was removed, but a surgical cut down was required. There was no report of patient death.
 
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Brand NameREDIGUARD IAB: 9FR 50CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
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 Key7659979
MDR Text Key113068117
Report Number3010532612-2018-00200
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K010330
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 06/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberIAB-R950-U
Device Lot NumberN/A
Other Device ID Number00801902010803
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 Received08/06/2018
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

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