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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: PACING 5 FR 110CM 25MM SPACIN; TEMPORARY PACING CATHETER
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ARROW INTERNATIONAL INC. CATH PKGD: PACING 5 FR 110CM 25MM SPACIN; TEMPORARY PACING CATHETER Back to Search Results
Catalog Number AI-07155
Device Problem Failure to Capture (1081)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/25/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the physician inserted catheter and couldn't capture cardiac signal while in use.As a result, the user changed the setting and connection of the catheter and the issue was resolved.There was no report of delay in therapy.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 "catheter couldn't capture cardiac signal" is not confirmed.The returned device passed functional test specifications.During functional testing, both distal and proximal electrodes met product specifications.The root cause of the complaint is undetermined.No further action required at this time.
 
Event Description
It was reported that the physician inserted catheter and couldn't capture cardiac signal while in use.As a result, the user changed the setting and connection of the catheter and the issue was resolved.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.
 
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Brand Name
CATH PKGD: PACING 5 FR 110CM 25MM SPACIN
Type of Device
TEMPORARY PACING CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8653888
MDR Text Key146804130
Report Number3010532612-2019-00162
Device Sequence Number1
Product Code LDF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAI-07155
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2019
Date Manufacturer Received06/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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