MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI KIT: 8.5 FR X 4" (10 CM); INTRODUCER CATHETER

Catalog Number ASK-09801-UAH

Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

Patient Problems Hypovolemia (2243); Insufficient Information (4580)

Event Date 06/27/2022

Event Type  Death  

Event Description

Customer complaint received reports "clinicians attempted to obtain iv access on a critically ill trauma patient using 4 to 5 introducer percutaneous sheath 8.5fx10cm custom-uah kits without success, due to the pliability of the 8.5 fr.X 4" (10 cm) arrow-flex radiopaque polyurethane with integral hemostasis valve/side port and tissue dilator.".It was reported the user attempted to place 4-5 sheaths without success and "each sheath collapsed or kinked and was not effective".This report captures the additional devices that were attempted to be placed (exact quantity unknown).It was reported the patient died on (b)(6) 2022 from hypovolemic cardiac shock and inability to replace significant fluid loss (captured in mdr report # 9680794-2022-00432).

Manufacturer Narrative

Qn# (b)(4).

Manufacturer Narrative

Qn#(b)(4).It was initially reported that "4 to 5" kits were used and found to be "too pliable".Additional information was requested regarding the complaint description.The clinician clarified on 30-aug-2022 that four sheaths were bent during use.They were all used on the same patient.The clinician also mentioned a fifth sheath that was bent; however, she could not confirm if it was used on a patient.Five complaints were opened to capture all events.Associated mdrs: 9680794-2022-00432, 9680794-2022-00433, 9680794-2022-00601, 9680794-2022-00602, 9680794-2022-00603.Corrected data: section h.1.-type of event corrected to "death".

Event Description

Customer complaint received reports "clinicians attempted to obtain iv access on a critically ill trauma patient using 4 to 5 introducer percutaneous sheath 8.5fx10cm custom-uah kits without success, due to the pliability of the 8.5 fr.X 4" (10 cm) arrow-flex radiopaque polyurethane with integral hemostasis valve/side port and tissue dilator.".It was reported the user attempted to place 4-5 sheaths without success and "each sheath collapsed or kinked and was not effective".It was reported the patient died on (b)(6) 2022 due to hypovolemic cardiac shock and inability to replace significant fluid loss.The customer alleges the device contributed to the patient's death because a central line could not be established for transfusion.It was reported the patient had suffered a severe trauma and had severe bleeding.Additional information received from the customer indicates the trauma to the patient was a "severe laceration to the neck".The sheath was attempted to be placed in the subclavian and femoral arteries.The patient was a male with no known underlying conditions.The customer also reports "no damage to the sheath was observed by the surgeon when it was first pulled out of the packaging.It was however kinking right at the articulated section of the sheath near the hub.".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: section e.1.-initial reporter name corrected to (b)(6).Section e.1.- initial reporter email corrected to (b)(6).

Event Description

Customer complaint received reports "clinicians attempted to obtain iv access on a critically ill trauma patient using 4 to 5 introducer percutaneous sheath 8.5fx10cm custom-uah kits without success, due to the pliability of the 8.5 fr.X 4" (10 cm) arrow-flex radiopaque polyurethane with integral hemostasis valve/side port and tissue dilator.".It was reported the user attempted to place 4-5 sheaths without success and "each sheath collapsed or kinked and was not effective".This report captures the additional devices that were attempted to be placed (exact quantity unknown).It was reported the patient died on (b)(6) 2022 from hypovolemic cardiac shock and inability to replace significant fluid loss (captured in mdr report # 9680794-2022-00432).

• Brand Name: ARROW PSI KIT: 8.5 FR X 4" (10 CM)
• Type of Device: INTRODUCER CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14956377
• MDR Text Key: 304100065
• Report Number: 9680794-2022-00433
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K780532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASK-09801-UAH
• Device Lot Number: 13F21J0927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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
• Treatment: NOT REPORTED; NOT REPORTED; NOT REPORTED
• Patient Outcome(s): Other; Death
• Patient Sex: Male