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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0500
Device Problems Mechanical Jam (2983); Incomplete or Inadequate Connection (4037)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/14/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Other remarks: see mdr# 3010532612-2019-00393 and (b)(4) as the report is related to the same device.
 
Event Description
It was reported the intra-aortic balloon pump (iabp) had a purge failure.As a result, the iabp was swapped out.The field service engineer (fse) was called in to service the iabp.Upon servicing the fse found that fill valve #2 was not opening as the helium was escaping through the 1 psi relief valve when the iabp attempted to fill.As a result, the pcs assembly was replaced.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4).Two complaints were opened in error for this reported complaint.The device was returned to teleflex for investigation.One part was returned for investigation for both complaints, and that part's failures can be the cause of both the complaints.The reported complaint was investigated and identified and will be captured under complaint mdr #3010532612-2019-00393, teleflex conformation no.(b)(4).Complaint mdr initial #, teleflex confirmation no.(b)(4) will be closed/canceled.Other remarks: see mdr# 3010532612-2019-00393 and tc (b)(4) as the report is related to the same device.
 
Event Description
It was reported the intra-aortic balloon pump (iabp) had a purge failure.As a result, the iabp was swapped out.The field service engineer (fse) was called in to service the iabp.Upon servicing the fse found that fill valve #2 was not opening as the helium was escaping through the 1 psi relief valve when the iabp attempted to fill.As a result, the pcs assembly was replaced.There was no report of patient complications, serious injury or death.
 
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Brand Name
AUTOCAT2 WAVE
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9278531
MDR Text Key183176333
Report Number3010532612-2019-00414
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIAP-0500
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2019
Date Manufacturer Received10/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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