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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH BASIC 20GAX6CM; CATHETER INTRAVASCULAR THERAPE
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ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH BASIC 20GAX6CM; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number EDC-00620-B
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/24/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
The complaint is reported as: during endurance placement the tip of the endurance catheter broke off from the main part of the catheter.It was reported the tip of the catheter was not removed from the patient and will remain in the patient's arm.No report of patient harm or complication.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).The customer returned one endurance catheter assembly for evaluation.Visual examination revealed the catheter tip was torn and separated.The distal separated portion of the catheter was not returned.The point of separation appeared jagged and angled, indicating contact with a sharp object likely caused the tear.The returned portion of the catheter body measured 53 mm , which indicates that at least 12 mm of the catheter body separated and was not returned per product drawing.The outer diameter of the catheter measured.043", which is within the specifications of 0.038"-0.048" per graphic.The inner diameter measured.032", which is within the specifications of 0.027"-0.037" per graphic.This indicates that the wall thickness measured as expected.The returned catheter was flushed using a lab inventory syringe.No defects were observed.A device history record review was performed with no relevant findings.The ifu provided with this kit instructs the user, "return catheter to its original position making sure juncture hub and catheter release tab fit tightly together and the distal tip of catheter is retracted past needle bevel." it also warns the user, "prior to insertion, distal tip of catheter must be fully retracted past needle bevel or catheter tip damage may occur" and "do not force catheter if resistance is encountered during advancement." the report of the catheter separation was confirmed by complaint investigation.The point of separation on the catheter appeared angled and jagged.This indicates that contact with a sharp object caused the separation (i.E.Needle bevel).No dimensional issues were found on the returned sample, and a device history record review was performed with no relevant findings to suggest a manufacturing related issue.Based on the received sample, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
 
Event Description
The complaint is reported as: during endurance placement the tip of the endurance catheter broke off from the main part of the catheter.It was reported the tip of the catheter was not removed from the patient and will remain in the patient's arm.No report of patient harm or complication.The patient's condition is reported as fine.
 
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Brand Name
ARROW EXT DWELL CATH BASIC 20GAX6CM
Type of Device
CATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10752003
MDR Text Key213691080
Report Number9680794-2020-00458
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K163513
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date10/31/2021
Device Catalogue NumberEDC-00620-B
Device Lot Number13F19L0108
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2020
Date Manufacturer Received11/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
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