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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW(R) VPS(R) ACCESS KIT; CATHETER, ULTRASOUND, INTRAVAS
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ARROW INTERNATIONAL LLC ARROW(R) VPS(R) ACCESS KIT; CATHETER, ULTRASOUND, INTRAVAS Back to Search Results
Catalog Number VPS-0072-BPK
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/05/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: the protective coating on the biosensor came off during insertion while on the inside of the patient.The entire biosensor was removed and they confirmed nothing was left inside the patient.No patient harm reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).One vps g4 g1+ legacy stylet assembly was returned.A visual examination revealed the sample was returned in two (2) pieces.Piece 1 is the basic stylet, including a complete ecg wire.Piece 2 is a partial section of the coaxial cable and the outer polyimide/ptfe tubing.It was reported "protective coating on the biosensor came off during insertion.Arrow vps stylet graphic specifies the stylet length is 35.000 +/- 0.250 inches from the end of the santoprene jacket.The ecg wire in returned sample piece 1 measured approximately 35 1/16 inches from the end of the santoprene jacket, indicating the ecg wire was complete and not separated.The polyimide/ptfe tubing and coaxial cable remaining on returned sample piece 1 measured approximately 18 12/16 inches from the end of the santoprene jacket.The coaxial cable in returned sample piece 2 measured approximately 16 4/16 inches.The two lengths combined (18 12/16 + 16 4/16) equals 35 inches meets the specification, which means the complete coaxial cable was recovered and returned.The encapsulated transducer was intact on the end of the coaxial cable.The separated polyimide/ptfe tubing in returned sample piece 2 measured approximately 18 12/16 inches with approximately 2 6/16 inches stretched and empty.The lengths of the returned polyimide/ptfe tubing indicate the complete length of tubing was recovered and returned.A microscopic examination of the separated areas did not reveal any specific causes for the separation of the stylet.A device history record review performed on the stylet did not reveal any manufacturing related issues.The reported issue "protective coating on the biosensor came off during insertion" was confirmed by evaluation of the returned vps g4 g1+ legacy stylet assembly.A visual examination revealed the sample was returned in two (2) pieces.Piece 1 is the basic stylet, including a complete ecg wire.Piece 2 is a partial section of the coaxial cable and the outer polyimide/ptfe tubing.The results of dimensional inspection concluded a complete stylet was returned and no pieces were left in the patient.The dimensional inspection revealed evidence of "stretching" of the tubing before separation.A microscopic examination of the separated areas did not reveal any specific causes for the separation of the stylet.A device history record review performed on the stylet did not reveal any manufacturing related issues.A probable cause of this issue could not be determined.No further action will be taken.Teleflex will continue to monitor and trend reports of this nature.
 
Event Description
The complaint is reported as: the protective coating on the biosensor came off during insertion while on the inside of the patient.The entire biosensor was removed and they confirmed nothing was left inside the patient.No patient harm reported.The patient's condition is reported as fine.
 
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Brand Name
ARROW(R) VPS(R) ACCESS KIT
Type of Device
CATHETER, ULTRASOUND, INTRAVAS
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX   31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key13586681
MDR Text Key288995709
Report Number9680794-2022-00145
Device Sequence Number1
Product Code OBJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103255
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date05/31/2023
Device Catalogue NumberVPS-0072-BPK
Device Lot Number13F21J0746
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/29/2022
Initial Date FDA Received02/23/2022
Supplement Dates Manufacturer Received03/29/2022
Supplement Dates FDA Received03/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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