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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 Problems Crack (1135); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/12/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It has been reported that the event involved patient. While in the cath lab the intra-aortic balloon (iab) was prepped and inserted via the patient's right femoral artery using a sheath. The patient was moved to the surgical intensive care unit (sicu). After three days of intra-aortic balloon pump (iabp) therapy the stopcock on the 6" pressure tubing fell apart. As a result the 6" tubing was removed and replaced. There was no reported patient death, injury or complications. Intra-aortic balloon pump (iabp) therapy was not interrupted or delayed. Medical / surgical intervention was not required. It was reported that the patient survived.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It has been reported that the event involved patient. While in the cath lab the intra-aortic balloon (iab) was prepped and inserted via the patient's right femoral artery using a sheath. The patient was moved to the surgical intensive care unit (sicu). After three days of intra-aortic balloon pump (iabp) therapy the stopcock on the 6" pressure tubing fell apart. As a result the 6" tubing was removed and replaced. There was no reported patient death, injury or complications. Intra-aortic balloon pump (iabp) therapy was not interrupted or delayed. Medical / surgical intervention was not required. It was reported that the patient survived.
 
Manufacturer Narrative
(b)(4). No product was returned for evaluation. 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. The reported complaint of "the stopcock on the 6" pressure tubing fell apart" is not able to be confirmed. No product was returned for evaluation. The root cause of the complaint is undetermined. If the sample is returned at a later date, a full investigation will be completed.
 
Event Description
It has been reported that the event involved patient. While in the cath lab the intra-aortic balloon (iab) was prepped and inserted via the patient's right femoral artery using a sheath. The patient was moved to the surgical intensive care unit (sicu). After three days of intra-aortic balloon pump (iabp) therapy the stopcock on the 6" pressure tubing fell apart. As a result the 6" tubing was removed and replaced. There was no reported patient death, injury or complications. Intra-aortic balloon pump (iabp) therapy was not interrupted or delayed. Medical / surgical intervention was not required. It was reported that the patient survived.
 
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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.
9 plymouth street
everett MA 02149
Manufacturer Contact
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key6167487
MDR Text Key62316790
Report Number1219856-2016-00281
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K981660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2018
Device Catalogue NumberIAB-S840C
Device Lot Number18F16H0059
Other Device ID Number00801902002679
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 Received01/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/29/2016
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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