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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 Detachment of Device or Device Component (2907)
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 the introducer was not securing to the sheath.Therefore the physician had to remove the pacemaker wire and start from the beginning and exchange of the sheath with a new kit, which ultimately worked.There was no report of patient death, serious injury or complications.
 
Event Description
It was reported that the introducer was not securing to the sheath.Therefore the physician had to remove the pacemaker wire and start from the beginning and exchange of the sheath with a new kit, which ultimately worked.There was no report of patient death, serious injury or complications.
 
Manufacturer Narrative
Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of dilator/sheath would not lock during use is not confirmed.The returned sample passed dimensional specifications and the dilator was able to advance through the sheath and lock with the sheath hub.Although, the root cause of the complaint is undetermined the returned device passed 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 Key8244906
MDR Text Key133194520
Report Number1036844-2019-00032
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 01/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2019
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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