MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW DOUBLE LUMEN CATHETER; CATHETER, INTRODUCER

Catalog Number VASCULAR UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Rash (2033); Tachycardia (2095)

Event Date 01/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Mw5067684.(b)(4).The product code, lot# and facility name not provided on the medwatch.Therefore, no additional information is available at this time.If any additional information is provided at a later date the complaint information will be updated accordingly.

Event Description

Medwatch# mw5067684 received.The medwatch provides the following information: the patient was brought to the operating room for a heart transplant, induced and intubated.The 9fr double lumen cordis was placed in the right femoral vein.Betadine prep was used (patient with prior history of chlorhexidine allergy).After placement, hemodynamically unstable, hypotension, tachycardia and was treated for anaphylaxis.Cpr initiated.Rash noted on chest.Alternative central line placed.The catheter in question was removed.The procedure was cancelled and transplant successfully performed at a later date.

Manufacturer Narrative

Qn#(b)(4).Medwatch# - mw5067684.The reported complaint of an allergic reaction where a double lumen 9fr catheter was in use could not be confirmed without a sample and further information.A review of the device history records could not be performed since the product code, lot number, and facility name was not provided on the medwatch report.The probable cause of this event could not be determined based upon the information provided and without a sample.

Event Description

Medwatch# mw5067684 received.The medwatch provides the following information: the patient was brought to the operating room for a heart transplant, induced and intubated.The 9fr double lumen cordis was placed in the right femoral vein.Betadine prep was used (patient with prior history of chlorhexidine allergy).After placement, hemodynamically unstable, hypotension, tachycardia and was treated for anaphylaxis.Cpr initiated.Rash noted on chest.Alternative central line placed.The catheter in question was removed.The procedure was cancelled and transplant successfully performed at a later date.

• Brand Name: ARROW DOUBLE LUMEN CATHETER
• Type of Device: CATHETER, INTRODUCER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6407131
• MDR Text Key: 70014582
• Report Number: 1036844-2017-00113
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: VASCULAR UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• 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
• Patient Outcome(s): Other; Required Intervention