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 Tachycardia (2095); Reaction (2414); Bronchospasm (2598)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).The specific event date, customer facility name/contact information, product code, lot#, patient condition and sample availability are all unknown.No further action is required at this time.If additional information is provided the complaint will be updated accordingly.

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)-year-old male with esrd secondary to type-ii diabetes presented for transplantation in 2012.He had a previously documented remote urticarial reaction to chx.Cefazolin and basiliximab were administered preoperatively.Anesthesia was induced with fentanyl, propofol and rocuronium.Shortly after cvl insertion, the patient developed bronchospasm, tachycardia, hypotension and a generalized rash which resolved with the administration of phenylephrine, diphenhydramine and ranitidine.The transplantation procedure was completed without further incident.Operating room records revealed that his cvl insertion site was prepared with iodine-based disinfectant, not chx.Nevertheless, the cvl used was also a chx-coated arrow g+ard blue plus.Both skin testing and immunocap testing for specific ige confirmed sensitization to chx".

Manufacturer Narrative

Qn#(b)(4).Patient codes (cont.) 1914 and 2033.The specific event date, customer facility name/contact information, product code, lot#, patient condition and sample availability are all unknown.No further action is required at this time.If additional information is provided the complaint will be updated accordingly.In the customer description, the customer stated that an arrow gard blue catheter was used as part of this procedure.The customer also indicated that the patient was confirmed to have had an allergy to chx (chlorohexidine), which is a contraindication to arrow gard blue catheters (which contains chx).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.The customer stated that a chlorohexidine coated catheter was used in the procedure.Additionally, it was confirmed that the patient suffered from an allergic reaction to chlorohexidine.Based on the information provided by the customer 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 41-year-old male with esrd secondary to type-ii diabetes presented for transplantation in 2012.He had a previously documented remote urticarial reaction to chx.Cefazolin and basilixmab were administered preoperatively.Anesthesia was induced with fentanyl, propofol and rocuronium.Shortly after cvl insertion, the patient developed bronchospasm, tachycardia, hypotension and a generalized rash which resolved with the administration of phenylephrine, diphenhydramine and ranitidine.The transplantation procedure was completed without further incident.Operating room records revealed that his cvl insertion site was prepared with iodine-based disinfectant, not chx.Nevertheless, the cvl used was also a chx-coated arrow g+ard blue plus.Both skin testing and immunocap testing for specific ige confirmed sensitization to chx".

• Brand Name: ARROW - UNKNOWN
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8802680
• MDR Text Key: 151440224
• Report Number: 9680794-2019-00279
• 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: foreign,other
• 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: 07/18/2019
• 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: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 41 YR