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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7FR X 20CM CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7FR X 20CM CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number CV-26702-E
Device Problems Kinked (1339); Folded (2630)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/06/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The customer returned one guide wire for evaluation. The catheter was not returned. The guide wire was separated and showed evidence of use. Visual examination revealed the guide wire is separated from the proximal weld and is kinked/distorted in several locations along the body. The guide wire body contains one severe kink at the center of the guide wire where the proximal coil wire has separated from the remaining spring coil. The separated proximal coil wire was returned and does not show significant unraveling. Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the proximal weld and that the weld was present at the end of the coil wire. The exposed proximal core wire tip is tapered and discolored at the point of separation. The distal j-bend of the guide wire was kinked but intact. Both welds appeared full and spherical. Visual inspection of the catheter could not be performed as the catheter was not returned. The major kinks in the guide wire body were measured at 2. 5, 23. 4, 39. 1 and 39. 5cm from distal weld. The separated coil wire measured 20. 8cm in length. The core wire overall length could not be accurately measured due to the severe kink in the guide wire body. The approximate overall length of the core wire was found to be within specification. Other remarks: the outside diameter (od) of the guide wire was also found to be within specification. A manual tug test confirmed that the distal weld was intact. A device history record review was performed on the guide wire and the catheter and no relevant manufacturing issues were identified. The instructions-for-use provided with this kit describes suggested techniques to minimize the likelihood of guide wire damage during use. The ifu states that if resistance is encountered when attempting to remove the spring wire guide after catheter placement, the spring wire guide may be kinked about the tip of the catheter within the vessel. In this circumstance, withdraw the catheter relative to the spring wire guide about 2-3 cm and attempt to remove the spring wire guide. If resistance is again encountered, remove the spring wire guide and catheter simultaneously. The report that the guide wire was damaged was confirmed through examination of the returned sample. The core wire was broken adjacent to the proximal weld and the proximal coil wire was separated from the guide wire body. No manufacturing defects were found during this investigation. Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2. 75 pounds force. This internal specification is higher than the bs en iso 11070:1999 standard of 2. 2 pounds force for this size wire. The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking. Guide wire breakage may occur if a force greater than the design specification is applied during removal. Based on these circumstances, it was determined that operational context likely contributed to this event, however, the probable cause of guide wire and catheter resistance could not be determined based upon the information provided and without the catheter being returned.
 
Event Description
It was reported that "there was a technical problem during the insertion of the cvc. The folding of the guide wire in several places cause of lack of possibility of insertion of the catheter. After replacing the set was possible to continue the insertion of the catheter. ".
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that "there was a technical problem during the insertion of the cvc. The folding of the guide wire in several places cause of lack of possibility of insertion of the catheter. After replacing the set was possible to continue the insertion of the catheter. ".
 
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Brand NameARROW CVC SET: 2-LUMEN 7FR X 20CM
Type of DeviceCATHETER,INTRAVASCULAR,THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6706082
MDR Text Key195845189
Report Number3006425876-2017-00222
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Catalogue NumberCV-26702-E
Device Lot Number71F16M0594
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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