MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI KIT: 6 FR; INTRODUCER CATHETER

Catalog Number	AK-09601
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the customer was using the psi kit with a 5fr swan-ganz bipoloar pacing catheter with the insertion site at the ij vein.The catheter migrated because the cath-gard supplied does not have a twistlock and the customer was unsuccessful at taping the catheter for securement.It was reported the patient experienced decreased heart rate and blood pressure, but no further information was available regarding these symptoms.No medical intervention was reported.The patient's current condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened psi kit for analysis.No definite signs of use were observed.It was noted that neither the tape nor the pacing catheter were returned for analysis.Visual analysis of the cath-gard did not reveal any defects or anomalies.There is no evidence to suggest that tape was ever applied to the cath-gard.Likewise, visual analysis could not be performed on the tape involved with this complaint as it was not returned for analysis.A lab inventory 5fr cvc catheter was inserted through the returned cath-gard.Little to no issue was observed as the catheter inserted completely through the cath-gard.Performed per ifu statement, "adapter end of catheter contamination shield should be secured with sterile tape to inhibit catheter movement".Functional testing could not be performed with the sterile tape as it was not returned for analysis.R & d was contacted as part of this complaint investigation.They revealed that these types of cath-guards are designed with a simple seal containing a hole on the proximal end (rather than a tuohy borst adapter).This end requires tape to hold the catheter in place.They also revealed that cath-gards of this type are not compatible with pacing catheters.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not apply tape to the transparent sheathing on the shield to reduce the risk of tearing material".The report of the cath-gard tape not secure could not be confirmed through complaint investigation.Visual and functional analysis did not reveal any defects on the returned cath-gard; however, the customer explicitly states that they used the cath-card in tandem with a pacing catheter.Per the comments from r & d, cathgards of this type are not meant to be used with pacing catheters.Therefore, intentional use error likely caused or contributed to this event as the device was used with an incompatible device.A customer in-service request has been initiated to further educate the customer on the correct use of this device.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported the customer was using the psi kit with a 5fr swan-ganz bipoloar pacing catheter with the insertion site at the ij vein.The catheter migrated because the cath-gard supplied does not have a twistlock and the customer was unsuccessful at taping the catheter for securement.It was reported the patient experienced decreased heart rate and blood pressure, but no further information was available regarding these symptoms.No medical intervention was reported.The patient's current condition is reported as fine.

• Brand Name: ARROW PSI KIT: 6 FR
• Common Device Name: 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: 17624429
• Report Number: 9680794-2023-00612
• Device Sequence Number: 6135933
• Product Code: DYB
• UDI-Device Identifier: 00801902005250
• UDI-Public: 00801902005250
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K780532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: AK-09601
• Device Lot Number: 13F21M0004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2021
• 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: 5FR SWAN-GANZ BIPOLOAR PACING CATHETER; 5FR SWAN-GANZ BIPOLOAR PACING CATHETER
• Patient Sex: Unknown