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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 Material Frayed (1262); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Patient Problem Laceration(s) (1946)
Event Date 09/25/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
The complaint is reported as, "at the time of removing the metal guide from the catheter, the doctor says that it becomes difficult, having to advance the catheter more than allowed to be able to remove the guide that at that time was bent, when the guide comes out the doctor finds it in his distal part open and frayed, causing lacerations in the intima of the vessel." no patient complication was reported.The patient's condition was reported as critical unrelated to the device issue.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
 
Event Description
The complaint is reported as: "at the time of removing the metal guide from the catheter, the doctor says that it becomes difficult, having to advance the catheter more than allowed to be able to remove the guide that at that time was bent, when the guide comes out the doctor finds it in his distal part open and frayed, causing lacerations in the intima of the vessel." no patient complication was reported.The patient's condition was reported as critical unrelated to the device issue.
 
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Brand Name
ARROW CVC SET: 2-LUMEN 7FR X 20CM
Type of Device
CATHETER,INTRAVASCULAR,THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10824061
MDR Text Key216009159
Report Number3006425876-2020-00945
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Type of Report Initial,Followup
Report Date 10/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date03/27/2022
Device Catalogue NumberCV-26702-E
Device Lot Number71F20F2150
Was Device Available for Evaluation? No
Date Manufacturer Received11/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
Patient Age82 YR
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