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 05/21/2017

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 pea (pulseless electrical activity) arrest during a kidney transplant in 2017.At that time, surgery was aborted.The troponin was elevated.The patient had an angiogram and coronary catheterization and stents placed.Patient again scheduled to receive renal transplant in 2019 and experienced subsequent pea arrest (captured in 9680794-2021-00502).Patient seen in anaphylaxis clinic and tested positive to chlorhexidine intradermal at 12 mm, and cholorhexidine skin prick test at 10 mm.The elevated troponin from both aborted kidney transplants felt to be consistent with an anaphylactic reaction.It was reported surgery 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 pea (pulseless electrical activity) arrest during a kidney transplant in 2017.At that time, surgery was aborted.The troponin was elevated.The patient had an angiogram and coronary catheterizaton and stents placed.Patient again scheduled to receive renal transplant in 2019 and experienced subsequent pea arrest (captured in 9680794-2021-00502).Patient seen in anaphylaxis clinic and tested positive to chlorhexidine intradermal at 12 mm, and cholorhexidine skin prick test at 10 mm.The elevated troponin from both aborted kidney transplants felt to be consistent with an anaphylactic reaction.It was reported surgery 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.

• Brand Name: ARROW CVC KIT
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• MDR Report Key: 12579243
• MDR Text Key: 274827371
• Report Number: 9680794-2021-00503
• 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: 11/02/2021
• 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: NONE REPORTED; NONE REPORTED; NONE REPORTED
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 51 YR