MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: WEDGE 6 FR 110 CM; CATHETER, FLOW DIRECTED

Catalog Number	AI-07126
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/25/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Qn# (b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
Received via a medwatch report, submitted by the risk manager at the health care facility, the report states "with ultrasound guidance, we obtained access to the right common femoral artery and vein with micro puncture needle and then advanced a 6 fr sheath over a wire in each using the seldinger approach.Arrow catheter was advanced in the pulmonary artery and used to obtain hemodynamics measurements.During catheter advancement over a j-wire to obtain accurate pulmonary wedge pressure, patient decompensated and went into respiratory arrest with hemoptysis and aspiration.This could have been secondary to possible catheter induced pulmonary artery rupture and pulmonary hemorrhage.Despite all emergent cardiopulmonary resuscitation efforts patient expired".The medwatch report states that the patient was an "84 [year old] female with history of htn, hlp, hfpef, moderate valvular disease and copd/osa admitted for chest pain and sob.Prior history of cardiac catheterization in 2021, with mild disease and echo in 2021 showing as and ai.Repeat echo in 6/23 showed preserved ef and moderate as.She was scheduled for op procedure but her symptoms got worse warranting her to come to the emergency department.Ekg showed sinus bradycardia with t-wave inversion.Hs trop 52-49-52, pro bnp 7183.Cxr shows cardiomegaly and mild pulmonary edema".Additional information received from the risk manager at the health care facility states that the cause of death was "undetermined".
Additional Manufacturer Narrative
(b)(4), the reported complaint of catheter difficult to advance in patient is not able to be confirmed as the product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
Received via a medwatch report, submitted by the risk manager at the health care facility, the report states "with ultrasound guidance, we obtained access to the right common femoral artery and vein with micro puncture needle and then advanced a 6 fr sheath over a wire in each using the seldinger approach.Arrow catheter was advanced in the pulmonary artery and used to obtain hemodynamics measurements.During catheter advancement over a j-wire to obtain accurate pulmonary wedge pressure, patient decompensated and went into respiratory arrest with hemoptysis and aspiration.This could have been secondary to possible catheter induced pulmonary artery rupture and pulmonary hemorrhage.Despite all emergent cardiopulmonary resuscitation efforts patient expired".The medwatch report states that the patient was an "84 [year old] female with history of htn, hlp, hfpef, moderate valvular disease and copd/osa admitted for chest pain and sob.Prior history of cardiac catheterization in 2021, with mild disease and echo in 2021 showing as and ai.Repeat echo in 6/23 showed preserved ef and moderate as.She was scheduled for op procedure but her symptoms got worse warranting her to come to the emergency department.Ekg showed sinus bradycardia with t-wave inversion.Hs trop 52-49-52, pro bnp 7183.Cxr shows cardiomegaly and mild pulmonary edema".Additional information received from the risk manager at the health care facility states that the cause of death was "undetermined".

• Brand Name: CATH PKGD: WEDGE 6 FR 110 CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18444330
• Report Number: 3010532612-2024-00010
• Device Sequence Number: 15497332
• Product Code: DYG
• UDI-Device Identifier: 00801902002877
• UDI-Public: 00801902002877
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F23D0043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 84 YR
• Patient Sex: Female