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 01/15/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical devices: ne (20 mg iv), propofol (250 mg iv), and rocuronium (80 mg iv)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: "admitted to hospital (b)(6) 2019, in order to undergo transcatheter aortic valve implantation for severe aortic stenosis.Induced around 8:00 in the morning with fentanyl (250 mcg iv), midazolam (1 mg iv), ketamine (20 mg iv), propofol (250 mg iv), and rocuronium (80 mg iv).We believe following the induction that a central line was placed, which was coated with chlorhexidine.Approximately 5 minutes after the patient was induced, his blood pressure dropped precipitously from 170/60 to 60/10.Tachycardiac up to the 140s.There was no rash or urticaria present at this time.The patient was given epinephrine boluses, a total of 3 mg iv push doses.Blood pressure was nonresponsive and dropped as low as 50/10.At this time, an epinephrine infusion was started as well as phenylephrine.The patient apparently received cpr briefly.Around 8:15, there was a rise in peak inspiratory pressure up to 37 cm of water, as well as increasing end-tidal co2 and an audible wheeze.The patient was treated as anaphylaxis with diphenhydramine 50 mg iv and hy drocorisone 100 mg iv.Blood pressure eventually stabilized around 8:45 on an epinephrine infustion.In the operating room, an x-ray was done which ruled out a pneumothorax, and a tee was also completed which showed normal biventricular contraction and hyperdynamic motion.A tryptase level was drawn at that time, which was elevated at 30.2." patient condition reported to be fine.The patient was transferred to the icu following this event, and the procedure was performed 2 days later with a central venous line without chlorhexidine and alternate anesthetic agents.There were no complications with this procedure, and the patient went home feeling well.

Manufacturer Narrative

Continuation of d11: ne (20 mg iv), propofol (250 mg iv), and rocuronium (80 mg iv).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 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.

Event Description

Through a review of records the customer reports a suspected allergic reaction to an arrow catheter.The following is reported: "admitted to hospital (b)(6) 2019, in order to undergo transcatheter aortic valve implantation for severe aortic stenosis.Induced around 8:00 in the morning with fentanyl (250 mcg iv), midazolam (1 mg iv), ketamine (20 mg iv), propofol (250 mg iv), and rocuronium (80 mg iv).We believe following the induction that a central line was placed, which was coated with chlorhexidine.Approximately 5 minutes after the patient was induced, his blood pressure dropped precipitously from 170/60 to 60/10.Tachycardiac up to the 140s.There was no rash or urticaria present at this time.The patient was given epinephrine boluses, a total of 3 mg iv push doses.Blood pressure was nonresponsive and dropped as low as 50/10.At this time, an epinephrine infusion was started as well as phenylephrine.The patient apparently received cpr briefly.Around 8:15, there was a rise in peak inspiratory pressure up to 37 cm of water, as well as increasing end-tidal co2 and an audible wheeze.The patient was treated as anaphylaxis with diphenhydramine 50 mg iv and hy drocorisone 100 mg iv.Blood pressure eventually stabilized around 8:45 on an epinephrine infustion.In the operating room, an x-ray was done which ruled out a pneumothorax, and a tee was also completed which showed normal biventricular contraction and hyperdynamic motion.A tryptase level was drawn at that time, which was elevated at 30.2." patient condition reported to be fine.The patient was transferred to the icu following this event, and the procedure was performed 2 days later with a central venous line without chlorhexidine and alternate anesthetic agents.There were no complications with this procedure, and the patient went home feeling well.

• Brand Name: ARROW CVC KIT
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• MDR Report Key: 12578463
• MDR Text Key: 274910873
• Report Number: 9680794-2021-00501
• 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

• Date FDA Received: 10/05/2021
• 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
• Date Manufacturer Received: 11/02/2021
• 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: FENTANYL (250 MCG IV), MIDAZOLAM (1 MG IV), KETAMI.; FENTANYL (250 MCG IV), MIDAZOLAM (1 MG IV), KETAMI.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR