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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PACING/PSI KIT: 5 FR/6 FR 2-L
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ARROW INTERNATIONAL INC. PACING/PSI KIT: 5 FR/6 FR 2-L Back to Search Results
Catalog Number AI-07155-IK
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/17/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a 5f pacing wire/6f introducer kit was used on a patient.Some difficulties were experienced: the introducer was not securing to the sheath.The hemostatic valve appeared to be defective as once they tried to secure the pacing wire, they continued to have bleed back through the valve.Ultimately, the physician had to remove the pacemaker wire and start from the beginning and exchange sheaths with a new kit, which ultimately worked.There was no report of patient injury or consequence.
 
Event Description
It was reported that a 5f pacing wire/6f introducer kit was used on a patient.Some difficulties were experienced: the introducer was not securing to the sheath.The hemostatic valve appeared to be defective as once they tried to secure the pacing wire, they continued to have bleed back through the valve.Ultimately, the physician had to remove the pacemaker wire and start from the beginning and exchange sheaths with a new kit, which ultimately worked.There was no report of patient injury or consequence.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of sheath leaked is not confirmed.No leaks were noted from the returned sheath.Although, the root cause of the complaint is undetermined the returned device passed visual and functional test specifications.No further action required at this time.
 
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Brand Name
PACING/PSI KIT: 5 FR/6 FR 2-L
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8237222
MDR Text Key132804517
Report Number1036844-2018-00319
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 12/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2019
Device Catalogue NumberAI-07155-IK
Device Lot Number23F18F0502
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2019
Date Manufacturer Received02/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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