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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 5 FR 110CM; CATHETER, FLOW DIRECTED
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ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 5 FR 110CM; CATHETER, FLOW DIRECTED Back to Search Results
Model Number IPN000070
Device Problem Inflation Problem (1310)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/08/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that testing on the table, the staff noted that the balloon was not inflating initially then inflated with difficulty.When the catheter was inserted into the patient the balloon stopped inflating.As a result, the catheter was removed and replaced.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of balloon would not inflate in use is not confirmed.During the investigation, no difficulty was noted upon inflating the balloon.The balloon inflated per specifications, and 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.
 
Event Description
It was reported that testing on the table, the staff noted that the balloon was not inflating initially then inflated with difficulty.When the catheter was inserted into the patient the balloon stopped inflating.As a result, the catheter was removed and replaced.There was no report of patient complications, serious injury or death.
 
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Brand Name
CATH PKGD: WEDGE 5 FR 110CM
Type of Device
CATHETER, FLOW DIRECTED
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10750282
MDR Text Key213657908
Report Number3010532612-2020-00323
Device Sequence Number1
Product Code DYG
UDI-Device Identifier00801902002853
UDI-Public00801902002853
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,foreig
Type of Report Initial,Followup
Report Date 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2021
Device Model NumberIPN000070
Device Catalogue NumberAI-07124
Device Lot Number16F20H0012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2020
Date Manufacturer Received11/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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