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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: PACING 6 FR 110 CM; TEMPORARY PACING CATHETER
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ARROW INTERNATIONAL INC. CATH PKGD: PACING 6 FR 110 CM; TEMPORARY PACING CATHETER Back to Search Results
Catalog Number AI-06210
Device Problem Failure to Capture (1081)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/14/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during insertion of the pacing catheter, the md reported that the wire was in good position but no capture.The md tried multiple positions, changed the pacer box, and changed the pacing cable set, but was still unable to get a capture.As a result, the catheter was removed and successfully replaced with another.There was no report of patient complication, serious injury or death.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of pacing catheter low/no signal is not confirmed.The returned device passed functional test specifications.During functional testing, both the 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 during insertion of the pacing catheter, the md reported that the wire was in good position but no capture.The md tried multiple positions, changed the pacer box, and changed the pacing cable set, but was still unable to get a capture.As a result, the catheter was removed and successfully replaced with another.There was no report of patient complication, serious injury or death.
 
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Brand Name
CATH PKGD: PACING 6 FR 110 CM
Type of Device
TEMPORARY PACING CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8666761
MDR Text Key147092280
Report Number3010532612-2019-00168
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 05/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2023
Device Catalogue NumberAI-06210
Device Lot Number16F18M0098
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2019
Date Manufacturer Received07/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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