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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PACING/PSI KIT: 5 FR 2-L; CATHETER, ELECTRODE RECORDING
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ARROW INTERNATIONAL INC. PACING/PSI KIT: 5 FR 2-L; CATHETER, ELECTRODE RECORDING Back to Search Results
Catalog Number AI-07155-KS
Device Problem Fluid/Blood Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 11/07/2023
Event Type  malfunction  
Event Description
The report states, "blood return from temp wire area within the swandom and blood within the sheath.I followed up with cc team and mentioned patient was shipped to bi boston for further ep testing with temp wire in place.I was told dr did see patient over the weekend, bleeding was maintained.Temp wire indication- bradycardia, syncope".
 
Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
 
Manufacturer Narrative
(b)(4).The reported complaint of sheath leaked was not able to be confirmed as the product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint was undetermined.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.
 
Event Description
The report states, "blood return from temp wire area within the swandom and blood within the sheath.I followed up with cc team and mentioned patient was shipped to bi boston for further ep testing with temp wire in place.I was told dr did see patient over the weekend, bleeding was maintained.Temp wire indication- bradycardia, syncope".
 
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Brand Name
PACING/PSI KIT: 5 FR 2-L
Type of Device
CATHETER, ELECTRODE RECORDING
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX   31200
Manufacturer Contact
kevin don bosco
3015 carrington mill blvd
morrisville 27560
MDR Report Key18133665
MDR Text Key328077076
Report Number9680794-2023-00925
Device Sequence Number1
Product Code DRF
UDI-Device Identifier10801902004533
UDI-Public10801902004533
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K945229
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2024
Device Catalogue NumberAI-07155-KS
Device Lot Number13F23A0501
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/07/2023
Initial Date FDA Received11/14/2023
Supplement Dates Manufacturer Received12/27/2023
Supplement Dates FDA Received01/02/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/23/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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