MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION UNK R2P¿; INTRODUCER, CATHETER

Model Number N/A

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

Patient Problems Headache (1880); Occlusion (1984); Visual Impairment (2138); Blood Loss (2597)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

Lot number: requested but not provided.Expiration date - unknown due to unknown part number/lot number.Udi - unknown due to unknown part number/lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - unknown due to unknown lot number.Pma/510(k)- unknown due to unknown part number/lot number.The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.

Event Description

The user facility reported that the patient received r2p treatment for superficial femoral artery (sfa) stenosis on (b)(6) 2019.The patient presented with elevated blood pressure (bp) during the procedure of over 200mmhg systolic.Post operation the patient complained of headaches.Post operation day two, the patient continued to complain of headaches and vision impairment and presented to the emergency department (ed).The patient was ambulatory with no motor deficits.The patient received a computed tomography (ct) and computed tomography angiography (cta), which confirmed a left p3 occlusion.The patient has subsequently been discharged and was reported to be asymptomatic.The estimated blood loss was less than 250cc.

Event Description

Additional information was received on june 24, 2019.The device functioned as intended in the procedure.The patient had elevated bp as noted, known vascular and peripheral artery disease, atrial fibrillation, cad and chf.The procedure was a left radial.The patient presented with a type ii arch resulting in difficulty navigating from subclavian into descending aorta during device insertion.Multiple catheters and wires were used.The patient had the following medication administered: intra-op nitro, verapamil, medazalam and fentanyl.

Event Description

Additional information was received on 19jul2019.The physician does not believe that the device contributed to the cause of these events.

Manufacturer Narrative

This report is being submitted as follow up no.2 to provide additional information to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.It is likely that the reported event was due to the patient disease state.However, with no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: UNK R2P¿
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8705339
• MDR Text Key: 148213607
• Report Number: 1118880-2019-00138
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2019

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: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/17/2019
• Supplement Dates Manufacturer Received: 06/24/2019; 07/19/2019
• Supplement Dates FDA Received: 07/18/2019; 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CATHETERS; FENTANYL; INTRA-OP NITRO; MEDAZALAM; VERAPAMIL; WIRES
• Patient Outcome(s): Other
• Patient Age: 79 YR