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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 6 FR 110 CM; CATHETER, FLOW DIRECTED
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ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 6 FR 110 CM; CATHETER, FLOW DIRECTED Back to Search Results
Model Number IPN000072
Device Problem Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/28/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported during the procedure, the doctor noticed the balloon has a leak and it was not the original shape.As a result, the catheter was removed and a new catheter was used to finish the procedure.There was no report of patient complications, serious injury or death.
 
Event Description
It was reported during the procedure, the doctor noticed the balloon has a leak and it was not the original shape.As a result, the catheter was removed and a new catheter was used to finish the procedure.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint that the "balloon has a leak" is not confirmed.The returned balloon passed functional testing and was fully intact.The returned device passed 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 6 FR 110 CM
Type of Device
CATHETER, FLOW DIRECTED
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10165149
MDR Text Key198685582
Report Number3010532612-2020-00164
Device Sequence Number1
Product Code DYG
UDI-Device Identifier00801902002877
UDI-Public00801902002877
Combination Product (y/n)N
PMA/PMN Number
K892530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 05/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN000072
Device Catalogue NumberAI-07126
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2020
Date Manufacturer Received07/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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