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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW RA CATH SET: 20 GA X 2-1/2"; WIRE GUIDE CATHETER
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ARROW INTERNATIONAL INC. ARROW RA CATH SET: 20 GA X 2-1/2"; WIRE GUIDE CATHETER Back to Search Results
Model Number IPN033172
Device Problems Difficult to Insert (1316); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/18/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
Customer reported that "the physician tried to insert the guidewire , but the guidewire insertion was difficult.The guidewire was kinking as a result the external surface of the guidewire detached from the internal surface of the guidewire".
 
Manufacturer Narrative
(b)(4).The customer returned one spring wire guide (swg) inserted in a needle as well as the swg advancer tubing for evaluation.Visual inspection revealed the core wire broke just proximal to the j-bend.The distal and proximal welds appeared full and spherical.A kink in the swg was also observed near where the wire was inserted into the needle hub.The swg was removed from the needle and dried blood was observed all along the swg body.The lengths of the core wire segments measured 22 mm and 434 mm, totaling 456 mm which is not within specification of 344-356 mm per swg product drawing.The outer diameter of the guide wire measured 0.02420" which is not within specification of 0.020"-0.021" per swg product drawing.The inner diameter of the needle cannula measured 0.041" which is not within specification of 0.0270"-0.0285" per cannula product drawing.It is hypothesized that the incorrect components were sent or the wrong material and lot number were reported.Neither can be confirmed.The undamaged portions of the swg were able to be inserted into the needle with minimal resistance.A device history record review was performed with no relevant findings to suggest a manufacturing related cause.The instructions for use (ifu) provided with this kit warns the user "do not withdraw spring-wire guide against needle bevel to avoid possible severing of spring-wire guide." the report that the guide wire was unraveled was confirmed through examination of the returned sample.The guide wire core wire was broken just proximal to the j-bend.A device history record review did not reveal any evidence of a manufacturing related issue.Dimensional inspection revealed that the returned swg and introducer needle did not match the product specifications of the components in the reported kit.Since the returned products did not belong to the kit reported, the root cause could not be determined.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
Customer reported that "the physician tried to insert the guidewire , but the guidewire insertion was difficult.The guidewire was kinking as a result the external surface of the guidewire detached from the internal surface of the guidewire.".
 
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Brand Name
ARROW RA CATH SET: 20 GA X 2-1/2"
Type of Device
WIRE GUIDE CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10104984
MDR Text Key193056395
Report Number9680794-2020-00260
Device Sequence Number1
Product Code DQX
Combination Product (y/n)N
PMA/PMN Number
K810675
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/29/2024
Device Model NumberIPN033172
Device Catalogue NumberGH-04120
Device Lot Number14F19B0329
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2020
Date Manufacturer Received06/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age50 YR
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