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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 Leak
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.

 
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Brand NamePACING/PSI KIT: 5 FR/6 FR 2-L
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford , MA 01824
9782505100
MDR Report Key8237222
Report Number1036844-2018-00319
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/17/2018
1 Device Was Involved in the Event
0 PatientS WERE 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
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/02/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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