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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM; CATHETER, HEMODIALYSIS. IMPLANTED
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ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM; CATHETER, HEMODIALYSIS. IMPLANTED Back to Search Results
Catalog Number CS-15242-VSP
Device Problem Air Leak (1008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer alleges that the catheter appeared faulty during insertion and allowed air into the arterial arm during first dialysis session.Issue resolved: discontinuation of dialysis procedure.Continuation of dialysis through the femoral temporary catheter inserted previously on (b)(6) 2017.Removal of the tunneled catheter next day.Patient complications - air bubbles in the arterial arm during dialysis no patient injury reported.
 
Manufacturer Narrative
(b)(4) the customer returned one hemodialysis catheter with "cannon ii plus" printed on the juncture hub.The catheter showed evidence of use.Visual inspection with the naked eye and under magnification did not reveal any defects of anomalies.The catheter was leak tested according to chronic hemodialysis catheter module requirements.The venous extension line was pressurized with water to 45psi with the venous tip occluded.As soon as the line was pressurized, water was seen leaking from the arterial tip.When the test was repeated for the arterial extension line, water was seen leaking from the venous tip.The hub connection assembly was then removed from the catheter body and reseated.The compression sleeve and compression cap where then threaded as described in the instructions-for-use (ifu).After reseating the leak test was repeated and no leaks were observed from either lumen.Therefore, it is believed the catheter was returned with the hub connection assembly seated incorrectly.A device history record review was performed on the catheter and no relevant manufacturing issues were identified.The ifu provided with this kit describes the technique for seating the hub connection assembly into the catheter body.It cautions to ensure that the compression sleeve is securely positioned inside the threaded compression cap and to avoid attempts to place compression sleeve onto hub connection assembly cannula and then apply threaded compression cap.The ifu also notes the green compression sleeve must be present when threading compression cap onto hub connection assembly.Failure to do so may result in air embolism, blood loss or catheter separation.The reported complaint of air being allowed into the arterial arm of the catheter was confirmed through functional testing of the returned complaint sample.It was determined through catheter leak testing that there was inter lumen crossover between the arterial and venous arms of the catheter.The catheter hub assembly was removed and then reseated according to the ifu and then retested.No leaking/crossover was observed during functional testing after the hub assembly was reseated.Based on the testing performed, it is believed the catheter was returned with the hub connector assembly incorrectly seated; therefore, it was determined that the probable cause for the complaint issue is operational context.
 
Event Description
The customer alleges that the catheter appeared faulty during insertion and allowed air into the arterial arm during first dialysis session.Issue resolved: discontinuation of dialysis procedure.Continuation of dialysis through the femoral temporary catheter inserted previously on (b)(6) 2017.Removal of the tunneled catheter next day.Patient complications - air bubbles in the arterial arm during dialysis no patient injury reported.
 
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Brand Name
ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM
Type of Device
CATHETER, HEMODIALYSIS. IMPLANTED
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6757722
MDR Text Key81518970
Report Number1036844-2017-00289
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodePL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2020
Device Catalogue NumberCS-15242-VSP
Device Lot Number23F17B0353
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age57 YR
Patient Weight62
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