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

Catalog Number	SI-09600
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that the temporary pacemaker required removal due to an mri procedure.Electrophysiology proceeded with changing the introducer, as the initial 8.5 fr introducer allowed blood to return to the pacemaker protector.A 6.0 fr introducer was used instead, but it was later observed that blood return persisted, and no smaller rf was available.The patient, being completely dependent on the pacemaker, remained under observation.Following an inflammatory response, blood cultures identified enterococcus faecalis, and antibiotic-coated treatment was initiated.
Additional Manufacturer Narrative
(b)(4) complaint verification testing could not be performed as it was reported that the sample is not available for return.Based on the nature of the complaint, a review of the instructions for use (ifu) was performed.The ifu states, "warning: hemostasis valve must be occluded at all times to reduce the risk of air embolism, contamination or hemorrhage.In the absence of an indwelling central catheter, use the arrow obturator to occlude hemostasis valve.".The customer was unable to provide more information regarding the reported pacemaker protector or the exact use of the psi device with other devices.It is unknown whether the customer used the cath-gard catheter contamination shield or a temporary pacing wire while the psi sheath was inserted.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit warns the user, "clinicians must be aware of complications or undesirable side effects associated with this device including but not limited to: exit site infection.Warning: hemostasis valve must be occluded at all times to reduce the risk of air embolism, contamination or hemorrhage.In the absence of an indwelling central catheter use the arrow obturator to occlude hemostasis valve." although the complaint can be confirmed based on the bacterial testing performed, the root cause of this event cannot be determined based on the available information and without a sample returned for investigation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that the temporary pacemaker required removal due to an mri procedure.Electrophysiology proceeded with changing the introducer, as the initial 8.5 fr introducer allowed blood to return to the pacemaker protector.A 6.0 fr introducer was used instead, but it was later observed that blood return persisted, and no smaller rf was available.The patient, being completely dependent on the pacemaker, remained under observation.Following an inflammatory response, blood cultures identified enterococcus faecalis, and antibiotic-coated treatment was initiated.

• Brand Name: ARROW PSI SET: 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: 21584901
• Report Number: 9680794-2025-00254
• Device Sequence Number: 18351019
• Product Code: DYB
• UDI-Device Identifier: 00801902101624
• UDI-Public: (01)00801902101624(11)221114(17)271031(10)14F22L0012(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 02/04/2025

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 Catalogue Number: SI-09600
• Device Lot Number: 14F22L0012
• 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: 02/04/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Male