MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW - UNKNOWN; CATHETER, PERCUTANEOUS

Catalog Number VASCULAR UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Reaction (2414)

Event Date 01/01/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to a case report in an article - canadian anesthesiologists society from 2019 for events that occurred in (b)(6): "this (b)(6) male with end-stage renal disease (esrd) secondary to hypertension and type-ii diabetes presented for renal transplantation in 2008.He had been on hemodialysis via an arterio-venous (av) arm fistula for six years.At that initial transplant operation, he received basiliximab pre-treatment followed by induction of anesthesia using midazolam, fentanyl, propofol and rocuronium.Shortly after cvl placement, the patient developed profound hypotension that progressed to a pulseless electrical activity (pea) cardiac arrest with a narrow complex tachycardia and st-segment depression, the operation was cancelled.Allergy skin tests to cefazolin, rocuronium and latex gave negative results as did immunocap testing for latex-specific ige.Basiliximab could not be obtained for skin testing and chx testing was also not performed".Transplantation was attempted again in 2009 using a regimen that did not include basiliximab or cefazolin.Anesthesia was induced with midazolam, fentanyl, propofol and rocuronium.During insertion of a cvl, he developed wheezing and hypotension that progressed to pea with a narrow complex tachycardia.Subsequent allergy testing to fentanyl, midazolam and propofol gave negative results.Repeat cardiology evaluation directed toward dynamic outflow tract obstruction was non-contributory.Although there were suggestions that these pea events were allergic in nature, a specific allergen was not identified.Serum tryptase was not measured".The patient was again re-scheduled for transplantation in 2011 with a plan to avoid agents to which the patient had previously been exposed, including latex, propofol, fentanyl, rocuronium, cefazolin and basiliximab.He received thiopental, remifentanil and cis-atracurium to induce general anesthesia.Approximately five to ten minutes following cvl insertion, the patient developed increased airway pressures followed by hypotension and then pea/ventricular tachycardia arrest.Serum tryptase was elevated 40 min after the arrest at 200 ugl.

Manufacturer Narrative

Qn#(b)(4).Patient codes (cont.) 1762, 3191 - (increased airway pressures).The patient involved with this complaint experienced three different events involving allergic reactions to arrow central catheters.Tc#1900070516, tc#1900070518, and tc#1900070519 were created to address the 3 separate events.For complaints 1900070516 and 1900070518 the customer stated that they were unable to identify the allergy; however, for complaint 1900070519 (the third event), the customer identified an allergy to chx (chlorohexidine), which is a contraindication for arrow gard blue coating (which contains chx).Visual inspection could not be performed as no sample was returned for analysis.The ifu for the finished kit involved with this complaint could not be reviewed as the material and lot numbers were not provided; however, the ifus for coated catheters in general state that, "the arrowg+ard blue antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine acetate, silver sulfadiazine, and/or sulfa drugs".A device history record review could not be performed as the material# and the lot# was not provided by the customer.The report of a catheter related allergic reaction was confirmed through the customer description of the events that occurred for complaints tc#1900070516, tc#1900070518, and tc#1900070519.The customer stated that a chlorohexidine coated catheter was used in each of these events.Additionally, it was confirmed that the patient suffered from an allergic reaction to chlorohexidine in tc#1900070519.Based on the information provided by the customer in tc#1900070519 and the confirmation that a coated catheter was used, unintentional user error (patient condition) caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

According to a case report in an article - canadian anesthesiologists society from 2019 for events that occurred in toronto, canada: "this 63-year-old male with end-stage renal disease (esrd) secondary to hypertension and type-ii diabetes presented for renal transplantation in 2008.He had been on hemodialysis via an arterio-venous (av) arm fistula for six years.At that initial transplant operation, he received basiliximab pre-treatment followed by induction of anesthesia using midazolam, fentanyl, propofol and rocuronium.Shortly after cvl placement, the patient developed profound hypotension that progressed to a pulseless electrical activity (pea) cardiac arrest with a narrow complex tachycardia and st-segment depression, the operation was cancelled.Allergy skin tests to cefazolin, rocuronium and latex gave negative results as did immunocap testing for latex-specific ige.Basiliximab could not be obtained for skin testing and chx testing was also not performed".Transplantation was attempted again in 2009 using a regimen that did not include basiliximab or cefazolin.Anesthesia was induced with midazolam, fentanyl, propofol and rocuronium.During insertion of a cvl, he developed wheezing and hypotension that progressed to pea with a narrow complex tachycardia.Subsequent allergy testing to fentanyl, midazolam and propofol gave negative results.Repeat cardiology evaluation directed toward dynamic outflow tract obstruction was non-contributory.Although there were suggestions that these pea events were allergic in nature, a specific allergen was not identified.Serum tryptase was not measured".The patient was again re-scheduled for transplantation in 2011 with a plan to avoid agents to which the patient had previously been exposed, including latex, propofol, fentanyl, rocuronium, cefazolin and basiliximab.He received thiopental, remifentanil and cis-atracurium to induce general anesthesia.Approximately five to ten minutes following cvl insertion, the patient developed increased airway pressures followed by hypotension and then pea/ventricular tachycardia arrest.Serum tryptase was elevated 40 min after the arrest at 200 ugl.

• Brand Name: ARROW - UNKNOWN
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8800135
• MDR Text Key: 151357839
• Report Number: 9680794-2019-00277
• Device Sequence Number: 1
• Product Code: DQY
• 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: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• 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: 08/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 63 YR