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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM; CATHETER, HEMODIALYSIS, NON-I
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ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM; CATHETER, HEMODIALYSIS, NON-I Back to Search Results
Model Number IPN030069
Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)
Patient Problem Death (1802)
Event Date 05/19/2020
Event Type  Death  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that it was impossible to advance the wire through the needle during the placement of an acute dialysis catheter.When finally, the placer drew back the wire, it got stuck in the needle.A new set was opened to place the catheter.The new attempt was successful, and catheter was placed without complications.It is reported that the patient is deceased.The user facility indicates that there is no link between the alleged issue with the device and the death of the patient.
 
Event Description
It was reported that it was impossible to advance the wire through the needle during the placement of an acute dialysis catheter.When finally, the placer drew back the wire, it got stuck in the needle.A new set was opened to place the catheter.The new attempt was successful, and catheter was placed without complications.It is reported that the patient is deceased.The user facility indicates that there is no link between the alleged issue with the device and the death of the patient.
 
Manufacturer Narrative
(b)(4).The customer returned one opened kit containing a guide wire assembly and introducer needle for evaluation.The guide wire was returned advanced through the introducer needle.Visual examination revealed the guide wire was unraveled from the distal end.The core wire separated adjacent to the distal weld, though the weld remained spherical.Microscopic examination of the fractured surface revealed the broken weld contained signs of necking, which indicates undue force caused the breakage.The guide wire body did not contain any significant kinks/bends.The core wire j-tip was fully formed.Visual examination of the returned introducer needle did not reveal any defects or anomalies.The total length of the returned core wire measured to be 695 mm which is within specifications of 694-706 mm per product drawing.The outer diameter of the guide wire (measured at the proximal end) measured to be 0.944 mm which is within specifications of 0.94-0.965 mm per product drawing.The inner diameter of the returned introducer needle measured to be 0.041" which is within specifications of 0.041-0.043" per product drawing.The returned guide wire was able to advance through the returned introducer needle with minimal resistance.A manual tug test confirmed the proximal weld was fully intact.A device history record review was performed on the guide wire and needle from this kit with no relevant findings.The instructions-for-use provided with this kit warns the user, "do not withdraw spring-wire guide against needle bevel to minimize the risk of possible severing or damaging of spring-wire guide." the customer report of guide wire/needle resistance (unraveled) was confirmed by complaint investigation of the returned sample.The guide wire was unraveled from the distal weld.The sample passed all relevant dimensional and functional testing, and a device history record review was performed with no relevant findings.The customer stated, "when finally the placer drew back the wire, it got stuck in the needle," which indicates the guide wire was withdrawn against the needle bevel.This contradicts the warning in the ifu that states "do not withdraw spring-wire guide against needle bevel to minimize the risk of possible severing or damaging of spring-wire guide." based on the customer description and sample investigation, intentional user error (not per ifu) caused or contributed to this event.An in-service has been requested to further educate the customer on proper use of this device.
 
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Brand Name
ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM
Type of Device
CATHETER, HEMODIALYSIS, NON-I
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10139132
MDR Text Key194668306
Report Number3006425876-2020-00529
Device Sequence Number1
Product Code MPB
Combination Product (y/n)N
PMA/PMN Number
K991431
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/28/2020
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 Health Professional
Device Expiration Date08/31/2023
Device Model NumberIPN030069
Device Catalogue NumberCS-12142-CF
Device Lot Number71F19G2787
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2020
Initial Date Manufacturer Received 05/28/2020
Initial Date FDA Received06/10/2020
Supplement Dates Manufacturer Received06/29/2020
Supplement Dates FDA Received06/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death; Other;
Patient Age87 YR
Patient Weight88
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