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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW TRAUMA SET: 7 FR; INTRODUCER, CATHETER

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ARROW INTERNATIONAL INC. ARROW TRAUMA SET: 7 FR; INTRODUCER, CATHETER Back to Search Results
Catalog Number RC-09700
Device Problem Material Separation (1562)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 10/02/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports a case of a retained wire while attempting to place a ric.There is no patient injury or consequence.The patient condition is reported as "fine".There are no patient complications or injury.Therapy was reported to be delayed/interrupted.Additional information: the thought is that the guide wire was lost while placing the ric line.It was found to be in the patient the next day (when the patient had an x-ray) and required an additional procedure (with ir) to remove it.It was removed successfully.
 
Event Description
The customer reports a case of a retained wire while attempting to place a ric.There is no patient injury or consequence.The patient condition is reported as "fine".There are no patient complications or injury.Therapy was reported to be delayed/interrupted.Additional information: the thought is that the guide wire was lost while placing the ric line.It was found to be in the patient the next day (when the patient had an x-ray) and required an additional procedure (with ir) to remove it.It was removed successfully.
 
Manufacturer Narrative
(b)(4).The sample was not returned for evaluation; however, the sales rep provided one photo for investigation.The photo was of the lidstock which provided the lot number and material number.The defect in the spring wire guide could not be confirmed through the photo.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit warns the user "do not apply excessive force in removing guide wire, dilator or sheath.If withdrawal cannot be easily accomplished, an x-ray should be obtained and further consultation requested." complaint verification testing could not be performed as no sample was returned for analysis and the provided photo was of only the lidstock.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
ARROW TRAUMA SET: 7 FR
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9213592
MDR Text Key177960628
Report Number9680794-2019-00408
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
PMA/PMN Number
K840455
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/08/2019
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? Yes
Device Operator No Information
Device Expiration Date03/31/2024
Device Catalogue NumberRC-09700
Device Lot Number14F19D0018
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/08/2019
Initial Date FDA Received10/21/2019
Supplement Dates Manufacturer Received11/08/2019
Supplement Dates FDA Received11/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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