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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 4 FR 110CM; CATHETER, FLOW DIRECTED
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ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 4 FR 110CM; CATHETER, FLOW DIRECTED Back to Search Results
Catalog Number AI-07122
Device Problem Inflation Problem (1310)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/24/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) would not inflate during use.As a result, the catheter was removed and a new catheter was used.There was no report of patient complications, serious injury or death.
 
Event Description
It was reported that the intra-aortic balloon (iab) would not inflate during use.As a result, the catheter was removed and a new catheter was used.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of balloon would not inflate in use is not confirmed.The balloon inflated as per specifications during the investigation.The returned device passed visual and functional test specifications.The root cause of the complaint is undetermined.A device history record (dhr) review was not performed.There was no confirmed product failure with the returned sample.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
 
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Brand Name
CATH PKGD: WEDGE 4 FR 110CM
Type of Device
CATHETER, FLOW DIRECTED
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8910903
MDR Text Key154890652
Report Number3010532612-2019-00285
Device Sequence Number1
Product Code DYG
Combination Product (y/n)N
PMA/PMN Number
K892530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAI-07122
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2019
Date Manufacturer Received09/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
N/A.; N/A.
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