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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER, INTRAVASCULAR, THERAPEUTIC
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ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Catalog Number CDC-45703-XP1A
Device Problem Difficult to Remove (1528)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 02/08/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).The results of the investigation are pending completion of the investigation.
 
Event Description
A report was received that when attempting to advance a catheter over the wire, it would not advance.The decision was made to remove the wire but it could not be removed by pulling back.As a result, a cut down was performed to remove the wire.The procedure was being performed on a trauma patient who expired.The attending trauma physician reported that the device did not cause or contribute to the patient's death.
 
Manufacturer Narrative
(b)(4).The sample was not returned for evaluation; however, the customer returned photographs.The photos showed a catheter and a guide wire that was unraveled toward the distal end.The proximal end of the catheter was not visible in the photos.No conclusions could be drawn about the cause of the unravelling without examining the actual sample.The ifu provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.It states that if resistance is encountered when attempting to remove the guide wire after catheter placement, the guide wire may be kinked about the tip of the catheter within the vessel.In this case it is recommended to withdraw the catheter relative to the guide wire about 2-3 cm and then attempt to remove the guide wire.The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire.Other remarks: complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and it did not reveal any manufacturing related issues.The probable cause of the guide wire unraveling could not be determined based upon the information provided and without a sample.If the sample is returned, a follow-up report will be submitted with investigation results.
 
Event Description
A report was received that when attempting to advance a catheter over the wire, it would not advance.The decision was made to remove the wire but it could not be removed by pulling back.As a result, a cut down was performed to remove the wire.The procedure was being performed on a trauma patient who expired.The attending trauma physician reported that the device did not cause or contribute to the patient's death.
 
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Brand Name
ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC
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 Key6391225
MDR Text Key69482524
Report Number1036844-2017-00103
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/31/2018
Device Catalogue NumberCDC-45703-XP1A
Device Lot Number23F16K0133
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/10/2017
Initial Date FDA Received03/09/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/06/2016
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;
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