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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW CVC KIT; CATHETER INTRAVASCULAR THERAPE
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ARROW CVC KIT; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number VASCULAR UNKNOWN
Device Problem Biocompatibility (2886)
Patient Problem Anaphylactic Shock (1703)
Event Date 05/08/2015
Event Type  Injury  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
Through a review of records the customer reports a suspected allergic reaction to an arrow catheter.The following information is provided: patient initially presented to the operating room, for an attempted open closure of her atrial septal defect (cardiac surgery) because of recurrent symptoms, including small embolic events and dyspnea.The surgical procedure, however, was not performed as shortly after induction the patient suffered cardiovascular collapse that was attributed to a probable anaphylactic reaction.She was managed with vasopressor, inotropic support and in fact, required emergency sternotomy and initiation of a short period of cardiopulmonary bypass.She was stabilized, weaned from bypass and transferred to the cs icu for continued management.She recovered adequately from this episode and underwent allergy testing.A serum tryptase level taken immediately following the acute event, was significantly elevated, in support of a true anaphylactic reaction.Unfortunately, no agent could be specified as the trigger for this reaction.Medications received at the time of this procedure included: sufentanil, midazolam, propofol, rocuronium.Patient had a second attempt at closure of the asd in 2016 and experienced a similar anaphylactic like reaction (captured in 9680794 -2021-00504).Subsequent, skin testing at the anaphylaxis clinic revealed an allergy to chlorhexidine.It was reported surgery was aborted.Patient condition reported to be fine.
 
Event Description
Through a review of records the customer reports a suspected allergic reaction to an arrow catheter.The following information is provided: patient initially presented to the operating room, for an attempted open closure of her atrial septal defect (cardiac surgery) because of recurrent symptoms, including small embolic events and dyspnea.The surgical procedure, however, was not performed as shortly after induction the patient suffered cardiovascular collapse that was attributed to a probable anaphylactic reaction.She was managed with vasopressor, inotropic support and in fact, required emergency sternotomy and initiation of a short period of cardiopulmonary bypass.She was stabilized, weaned from bypass and transferred to the cs icu for continued management.She recovered adequately from this episode and underwent allergy testing.A serum tryptase level taken immediately following the acute event, was significantly elevated, in support of a true anaphylactic reaction.Unfortunately, no agent could be specified as the trigger for this reaction.Medications received at the time of this procedure included: sufentanil, midazolam, propofol, rocuronium.Patient had a second attempt at closure of the asd in 2016 and experienced a similar anaphylactic like reaction (captured in 9680794 -2021-00504).Subsequent, skin testing at the anaphylaxis clinic revealed an allergy to chlorhexidine.It was reported surgery was aborted.Patient condition reported to be fine.
 
Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.Because the product code was not known, two potential finished good codes were identified based upon additional information received from the sales representative.Based upon the event date, the associated potential lot numbers for each finished good was identified from sales history.The device history records for both potential lots were reviewed.No relevant findings were identified to suggest a manufacturing related issue.The customer report of an allergic reaction was confirmed by the event details of the reported complaint.The patient had an allergic reaction and later was confirmed to have a chlorhexidine allergy.Chlorhexidine is included in the coating of the catheter in this kit.The device history records for two potential finished good codes and associated lot numbers identified from sales history were reviewed.No relevant findings were identified to suggest a manufacturing related issue.The instructions-for-use (ifu) provided states the arrowg+ard blue plus antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine, and/or sulfa drugs.Based on the information provided, unintentional use error (patient condition) likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
 
Event Description
Through a review of records the customer reports a suspected allergic reaction to an arrow catheter.The following information is provided: patient initially presented to the operating room, for an attempted open closure of her atrial septal defect (cardiac surgery) because of recurrent symptoms, including small embolic events and dyspnea.The surgical procedure, however, was not performed as shortly after induction the patient suffered cardiovascular collapse that was attributed to a probable anaphylactic reaction.She was managed with vasopressor, inotropic support and in fact, required emergency sternotomy and initiation of a short period of cardiopulmonary bypass.She was stabilized, weaned from bypass and transferred to the cs icu for continued management.She recovered adequately from this episode and underwent allergy testing.A serum tryptase level taken immediately following the acute event, was significantly elevated, in support of a true anaphylactic reaction.Unfortunately, no agent could be specified as the trigger for this reaction.Medications received at the time of this procedure included: sufentanil, midazolam, propofol, rocuronium.Patient had a second attempt at closure of the asd in 2016 and experienced a similar anaphylactic like reaction (captured in 9680794 -2021-00504).Subsequent, skin testing at the anaphylaxis clinic revealed an allergy to chlorhexidine.It was reported surgery was aborted.Patient condition reported to be fine.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.Because the product code was not known, two potential finished good codes were identified based upon additional information received from the sales representative.Based upon the event date, the associated potential lot numbers for each finished good was identified from sales history.The device history records for both potential lots were reviewed.No relevant findings were identified to suggest a manufacturing related issue.The customer report of an allergic reaction was confirmed by the event details of the reported complaint.The patient had an allergic reaction and later was confirmed to have a chlorhexidine allergy.Chlorhexidine is included in the coating of the catheter in this kit.The device history records for two potential finished good codes and associated lot numbers identified from sales history were reviewed.No relevant findings were identified to suggest a manufacturing related issue.The instructions-for-use (ifu) provided states the arrowg+ard blue plus antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine, and/or sulfa drugs.Based on the information provided, unintentional use error (patient condition) likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
 
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Brand Name
ARROW CVC KIT
Type of Device
CATHETER INTRAVASCULAR THERAPE
MDR Report Key12579463
MDR Text Key274827831
Report Number9680794-2021-00505
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberVASCULAR UNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received11/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SUFENTANIL, MIDAZOLAM, PROPOFOL, ROCURONIUM; SUFENTANIL, MIDAZOLAM, PROPOFOL, ROCURONIUM; SUFENTANIL, MIDAZOLAM, PROPOFOL, ROCURONIUM; SUFENTANIL, MIDAZOLAM, PROPOFOL, ROCURONIUM
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age41 YR
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