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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-S840C
Device Problems Device Alarm System (1012); Fluid/Blood Leak (1250); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/16/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint of blood in helium pathway is confirmed. Two cuts consistent with contact from a sharp object were found on the bladder membrane which likely allowed blood to enter the helium pathway. Although, the root cause of the bladder damage is undetermined but a potential cause is a result of customer handling. 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 assessed the risk for the reported complaint. There are no new or revised risks. This issue will be monitored for any developing trends. No further action required at this time.
 
Event Description
It was reported a patient of 169cm in height with an intra-aortic balloon (iab) the pump alarmed after 15 mins use. Helium leak alarm, blood was observed in the catheter. Indicating the balloon was broken. Patient outcome: fine. There was no reported death or complications to the patient.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported a patient of (b)(6) height with an intra-aortic balloon (iab) the pump alarmed after 15 mins use. Helium leak alarm, blood was observed in the catheter. Indicating the balloon was broken. Patient outcome: fine. There was no reported death or complications to the patient.
 
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Brand NameREDIGUARD IAB: 8FR 40CC
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 Key7145203
MDR Text Key266192282
Report Number1219856-2017-00318
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCH
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 11/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Catalogue NumberIAB-S840C
Device Lot Number18F17F0001
Other Device ID Number00801902002679
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/26/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2017
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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