MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number CDC-21242-XCN1A

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 01/05/2024

Event Type  Injury  

Event Description

It was reported that: patient coded twice and had a chlorhexidine allergic reaction.Additional information: it was known that the patient had a chg allergy prior to the procedure.He had a previous arrest during a cabg because of the allergy.Precautions were taken with medication selection and avoiding any chg scrubs or cleaners for the surgery.When the sheath was inserted the patient became tachycardic and hypotensive.Once the reaction started, he was treated with bolus of epinephrine and a gtt was started along with vasopressin, compressions were started for perfusion only as the patient did not lose pulse.Once the surgical team realized it was the sheath it was removed immediately and replace with a sheath that was not coated.The patient was transferred to icu following the procedure with hemodynamics that would be within normal limits after a cabg, meaning that he required a little extra blood pressure support initially but was able to be weaned off.The patient did develop an ileus after the procedure but was unlikely as a result of the anaphylaxis event.There was no further health consequences.The patient has been discharged home with home help.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: patient coded twice and had a chlorhexidine allergic reaction.Additional information: it was known that the patient had a chg allergy prior to the procedure.He had a previous arrest during a cabg because of the allergy.Precautions were taken with medication selection and avoiding any chg scrubs or cleaners for the surgery.When the sheath was inserted the patient became tachycardic and hypotensive.Once the reaction started, he was treated with bolus of epinephrine and a gtt was started along with vasopressin, compressions were started for perfusion only as the patient did not lose pulse.Once the surgical team realized it was the sheath it was removed immediately and replace with a sheath that was not coated.The patient was transferred to icu following the procedure with hemodynamics that would be within normal limits after a cabg, meaning that he required a little extra blood pressure support initially but was able to be weaned off.The patient did develop an ileus after the procedure but was unlikely as a result of the anaphylaxis event.There was no further health consequences.The patient has been discharged home with home help.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer.No relevant findings were identified.The instructions for use (ifu), which is included in the device packaging, was reviewed.It states, "contraindications: the arrowg+ard blue antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs." follow-up with the customer revealed that further lab testing confirmed that the patient had an allergy to chlorhexidine.The report of a catheter related allergic reaction was confirmed based on the customer report and additional information received from the customer.The customer follow-up confirmed that the patient had an allergy to chlorhexidine.The labeling provided with this kit states "the arrowg+ard blue antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs." therefore, based on the reported event and customer confirmation of the patient having an allergy , unintentional use error (patient condition) likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB
• Type of Device: CATHETER,INTRAVASCULAR,THERAPE
• 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 Key: 18666318
• MDR Text Key: 334833419
• Report Number: 9680794-2024-00136
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

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?: No
• Device Catalogue Number: CDC-21242-XCN1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/04/2024
• 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: NOT REPORTED; NOT REPORTED
• Patient Outcome(s): Required Intervention
• Patient Sex: Male