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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 8" (20 CM) AGB+ CATHETER, INTRAVASCULAR, THERAPEUTIC

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ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 8" (20 CM) AGB+ CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Catalog Number ASK-45703-PLGH1
Device Problems Break (1069); Unraveled Material (1664); Physical Resistance (2578)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 04/13/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). The physician reports the patient was septic and death not related to the line mishap but rather to peripheral vascular disease.
 
Event Description
The customer reports that during use the guidewire unraveled from the 'core' and the j-tip broke off along with a portion of the unraveled wire in the patient. A surgical intervention was scheduled to retrieve the wire but the patient passed away before this could take place. The customer further explains details of the event: the needle was inserted into the left subclavian without ultrasound guidance. He inserted the. 025" spring wire guide and met resistance past the needle. He lowered his angle and attempted to pass the wire again. We felt resistance and knew there was a kink in the wire. He pulled the wire back against the needle bevel to pass the wire into the vessel again. The wire unraveled. He then pulled the wire and needle back as one unit until it was outside of the patient. That's when he realized the tip was gone. In retrospect, he didn't appreciate the severity of the bend in the wire before pulling it back against the needle bevel.
 
Manufacturer Narrative
(b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed and no relevant findings were identified. An in-service request was initiated based on the customer report that they withdrew the guide wire against the needle bevel, which the ifu explicitly cautions the user against doing. 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.
 
Event Description
The customer reports that during use the guidewire unraveled from the 'core' and the j-tip broke off along with a portion of the unraveled wire in the patient. A surgical intervention was scheduled to retrieve the wire but the patient passed away before this could take place. The customer further explains details of the event: the needle was inserted into the left subclavian without ultrasound guidance. He inserted the. 025" spring wire guide and met resistance past the needle. He lowered his angle and attempted to pass the wire again. We felt resistance and knew there was a kink in the wire. He pulled the wire back against the needle bevel to pass the wire into the vessel again. The wire unraveled. He then pulled the wire and needle back as one unit until it was outside of the patient. That's when he realized the tip was gone. In retrospect, he didn't appreciate the severity of the bend in the wire before pulling it back against the needle bevel.
 
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Brand NameARROW PI CVC KIT: 3-L 7 FR X 8" (20 CM) AGB+
Type of DeviceCATHETER, 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 Key7498016
MDR Text Key107708233
Report Number1036844-2018-00126
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
Type of Report Initial,Followup
Report Date 04/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue NumberASK-45703-PLGH1
Device Lot Number23F18A0473
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/22/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/09/2018 Patient Sequence Number: 1
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