MAUDE Adverse Event Report: ARROW CVC KIT; CATHETER INTRAVASCULAR THERAPE

Catalog Number VASCULAR UNKNOWN

Device Problem Biocompatibility (2886)

Patient Problem Anaphylactic Shock (1703)

Event Date 04/15/2019

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 is reported: patient with prior pea (pulseless electrical activity) arrest in 2017 during a kidney transplant (captured in 9680794-2021-00503).In (b)(6) 2019, patient was again scheduled to receive a renal transplant from a deceased donor.Shortly after induction of anesthesia, he developed severe hypotension and had a subsequent pea arrest.The kidney transplant was once again aborted.Again elevated troponin.A coronary angiogram, showed the previously placed lad stent, was widely patent.There was mild to moderate distal left circumflex disease, but this did not explain his cardiac arrest.Patient was again discharged without a diagnosis.On review on the patient in the anaphylaxis clinic.Patient states that when exposed to chlorhexidine on skin, will develop pruritus and subsequently hives.Patient routinely will tell his dialysis nurses to clean his fistula with alcohol or saline.Going back through his history, he had an acute reaction to chlorhexidine while getting dialysis on (b)(6) 2018.At that time, the pt age was (b)(6).In testing in the allergy clinic, tested to latex, cefazolin, propofol, lidocaine, and cisatracurium where negative for all these substances.He tested positive to chlorhexidine intradermal at 12 mm, and chlorhexidine skin prick test at 10 mm.Appropriate histamine and saline controls.The elevated troponin from both aborted kidney transplants is felt to be consistent with an anaphylactic reaction.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 is reported: patient with prior pea (pulseless electrical activity) arrest in 2017 during a kidney transplant (captured in 9680794-2021-00503).In (b)(6) 2019, patient was again scheduled to receive a renal transplant from a deceased donor.Shortly after induction of anesthesia, he developed severe hypotension and had a subsequent pea arrest.The kidney transplant was once again aborted.Again elevated troponin.A coronary angiogram, showed the previously placed lad stent, was widely patent.There was mild to moderate distal left circumflex disease, but this did not explain his cardiac arrest.Patient was again discharged without a diagnosis.On review on the patient in the anaphylaxis clinic.Patient states that when exposed to chlorhexidine on skin, will develop pruritus and subsequently hives.Patient routinely will tell his dialysis nurses to clean his fistula with alcohol or saline.Going back through his history, he had an acute reaction to chlorhexidine while getting dialysis on (b)(6) 2018.At that time, tryptase was 52.In testing in the allergy clinic, tested to latex, cefazolin, propofol, lidocaine, and cisatracurium where negative for all these substances.He tested positive to chlorhexidine intradermal at 12 mm, and chlorhexidine skin prick test at 10 mm.Appropriate histamine and saline controls.The elevated troponin from both aborted kidney transplants is felt to be consistent with an anaphylactic reaction.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 the sales history of the customer.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.

• Brand Name: ARROW CVC KIT
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• MDR Report Key: 12578922
• MDR Text Key: 276651727
• Report Number: 9680794-2021-00502
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: VASCULAR UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 10/05/2021
• Supplement Dates Manufacturer Received: 11/02/2021
• Supplement Dates FDA Received: 11/03/2021
• 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 Number: 1
• Treatment: ANESTHESIA; ANESTHESIA
• Patient Outcome(s): Life Threatening; Required Intervention