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 01/01/2009

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): "a (b)(6) male with idiopathic esrd treated with hemodialysis since 1995 presented for a cadaveric renal transplant 2009.A cvl arrow g+ard blue plus was inserted in the internal jugular vein.Shortly afterwards, the patient's peak airway pressures increased to 32/5 cmh2o and his o2 saturation fell to 92%.Systolic blood pressure transiently decreased from 120 to 100 mmhg and there was an increase heart rate to 70-90 beats/min.A red rash was noted on his chest.The transplantation procedure was completed without further incident.Serum tryptase was not measured".

Manufacturer Narrative

(b)(4).Patient codes (cont.) - 2477,2033, 3191-( airway pressure increase).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.The customer stated that the patient developed a reaction after an arrow gard blue plus was inserted.Arrow gard blue plus catheters are contraindicated for patients with known hypersensitivity to chlorhexidine acetate, silver sulfadiazine, and/or sulfa drugs; however, the customer did not indicate if the patient had an allergy or had been tested for an allergy to any of the listed substances.A device history record review could not be performed as the material# and the lot# was not provided by the customer.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".The report of a catheter related allergic reaction could not be confirmed through complaint investigation.The customer stated that a arrow gard blue plus coated catheter (contraindicated for chlorohexidine) was used; however, the customer did not indicate that the patient had an allergy to chlorohexidine or was tested for an allergy to chlorohexidine.Based on the information provided by the customer, the root cause cannot be determined at this time.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: "a 30-year-old male with idiopathic esrd treated with hemodialysis since 1995 presented for a cadaveric renal transplant 2009.A cvl arrow g+ard blue plus was inserted in the internal jugular vein.Shortly afterwards, the patient's peak airway pressures increased to 32/5 cmh2o and his o2 saturation fell to 92%.Systolic blood pressure transiently decreased from 120 to 100 mmhg and there was an increase heart rate to 70-90 beats/min.A red rash was noted on his chest.The transplantation procedure was completed without further incident.Serum tryptase was not measured".

• Brand Name: ARROW - UNKNOWN
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8802584
• MDR Text Key: 151436802
• Report Number: 9680794-2019-00278
• 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: 30 YR