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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
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ARROW INTERNATIONAL INC. CATH PKGD: PACING 6 FR 110 CM 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 08/29/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that when the catheter was in use the doctor noted that a capture was unable to be achieved and multiple attempts were made with no change.As a result, due to the urgency of the patient, the doctor decided to the change the electrode and was able to achieve a capture.There was no report of patient complications, serious injury or death.
 
Event Description
It was reported that when the catheter was in use the doctor noted that a capture was unable to be achieved and multiple attempts were made with no change.As a result, due to the urgency of the patient, the doctor decided to the change the electrode and was able to achieve a capture.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4).No parts were returned to teleflex chelmsford for investigation.The reported complaint of pacing catheter low/no signal is not able to be confirmed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.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: PACING 6 FR 110 CM
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10631447
MDR Text Key210634999
Report Number3010532612-2020-00282
Device Sequence Number1
Product Code DYG
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 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAI-06210
Device Lot Number16F20E0017
Was Device Available for Evaluation? No
Date Manufacturer Received11/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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