MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CATH-LAB SHEATH INTRO SET; CATHETER PERCUTANEOUS

Model Number	IPN000142
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d11: ventilator.Qn# (b)(4).
Event or Problem Description
It was reported medical staff observed a disconnection of the tubing of the introducer valve used to perform reperfusion of the inferior member.The arterial flow applied to the femoral reperfusion line was 2 l/min.The patient consequence was reported as "continuous bleeding with risk of exsanguination".Staff secured the connection by a suture thread by the anesthetist-resuscitator while waiting for the removal of the assistance.The patient's current condition is reported as "patient has cardiac support.Wake-up delay during exploration.The patient is alive.".
Event or Problem Description
It was reported medical staff observed a disconnection of the tubing of the introducer valve used to perform reperfusion of the inferior member.The arterial flow applied to the femoral reperfusion line was 2 l/min.The patient consequence was reported as "continuous bleeding with risk of exsanguination".Staff secured the connection by a suture thread by the anesthetist-resusciatator while waiting for the removal of the assistance.The patient's current condition is reported as "patient has cardiac support.Wake-up delay during exploration.The patient is alive.".
Additional Manufacturer Narrative
Continuation of d11: ventilatorqn#(b)(4).The report of side arm separation could not be confirmed through complaint investigation.The customer provided one photo for analysis which revealed the sheath in use on the patient and the complaint of sheath side arm separation could not be identified from the photo.The customer returned one cath-lab sheath for investigation.Signs of use were observed in the form of biological material inside and on the side arm.Visual analysis revealed that the sheath was returned with a suture wrapped around the side arm and haemostasis valve.The suture was removed from the side arm to better visualize the junction between the side arm and haemostasis valve body.Visual examination with and without microscopy did not reveal any anomalies on the side arm or valve body.The sheath appeared typical as there was no visual evidence of separation between the side arm and valve body.Dimensional inspection was performed on the side arm with calipers.The side arm outer diameter (od) was measured 0.1305", which is within the specifications of 0.130"-0.134", per product drawing.The side arm inner diameter (id) was not measured so that functional testing would not be impacted by the disassembling of the components.The hemostasis valve and sheath were leak tested according to iso 11070 with and without a lab inventory obturator occluding the valve.The sheath was attached to the lab leak tester.In low-pressure leak resistance test, the sheath was pressurized to 21kpa for greater than 30 seconds with the distal end of the sheath occluded.No leaks were observed, which indicates that the sheath valves were functioning as intended.In high pressure leak resistance test, the device was pressurized to 300kpa for greater than 30 seconds with both the distal end of the sheath and the hemostasis valve occluded with a lab inventory obtuator.No leaks were detected from any portion of the psi, which indicates that the sheath assembly is intact.The returned device passed both the functional leak tests performed.This indicates that there is no identifiable separation between the side arm and hemos tasis valve.Therefore, the customer reported issue could not be reproduced during lab testing.No functional defects were identified with the returned device.Additionally, the ifu provided with the kit informs the user, "use arrow obturator, either included with this product or sold separately, as dummy catheter with hemostasis valve/side port assembly and sheath.This will ensure that leakage does not occur, and inner seal is protected from contamination".A device history record review was performed based on a potential lot from sales history and no relevant findings were identified.It is possible that the customer may have reconnected the side arm sufficiently enough during the reported separation that the issue can no longer be identified.Use of sutures around the valve and side arm indicates that the reported event likely occurred but cannot be confirmed as the returned device meets all specifications and functional requirements.Based on these circumstances, the probable root cause for the reported issue cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CATH-LAB SHEATH INTRO SET
• Common Device Name: CATHETER PERCUTANEOUS
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17019414
• Report Number: 9680794-2023-00357
• Device Sequence Number: 20404729
• Product Code: DQY
• UDI-Device Identifier: 00801902001900
• UDI-Public: 00801902001900
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

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 Model Number: IPN000142
• Device Catalogue Number: CL-07724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARDIOPULMONARY ASSISTANCE WITH REPERFUSION LINE,; CARDIOPULMONARY ASSISTANCE WITH REPERFUSION LINE,
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Unknown