MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CATH PKGD: WEDGE 5 FR 110CM; CATHETER, FLOW DIRECTED

Catalog Number	AI-07124
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " wedge catheter would not flush or give hemodynamic reading.Catheter flushed before entering the body.Took back out of the body and it would not flush".No additional informaion from the customer has been provided.If additional information is received, the complaint file will be updated.
Event or Problem Description
It was reported " wedge catheter would not flush or give hemodynamic reading.Catheter flushed before entering the body.Took back out of the body and it would not flush".No additional information from the customer has been provided.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 5fr 110cm wedge catheter with the original packaging pouch.The sample was returned in a cardboard box and was loosely packed within the original packaging pouch.Upon return, the supplied control stroke syringe was connected to the inflation lumen stop-cock.The inflation lumen stopcock was in the closed position.The recommended volume capacity of the balloon is 0.75cc.Upon microscopic inspection, the balloon appeared typical; no damage or abnormalities were noted to the balloon.No condensation was noted within the inflation lumen exten-sion line.No blood or contrast media was noted within the injection lumen extension line.Dried blood was noted on the exterior surfaces of the returned sample.No visual damage or abnormalities were noted to the returned sample.The inflation lumen was injected with 0.75cc of air using the returned control stroke syringe.The balloon inflated symmetrically.One side of the balloon measured approx-imately 4mm.The other side measured approximately 4mm.The balloon did meet specifications per graphic of radius ratio less than or equal to 2.0.The inflation lumen was injected with 0.75cc of air using the returned control stroke syringe.The balloon inflated successfully without any difficulty and was noted symmetrical.The balloon deflated in less than 3 seconds when the syringe was removed per specification.No pull away was noted after the tug test.The balloon was placed in water and air was injected into the inflation lumen again.No leak was noted.An attempt to aspirate and flush the injection lumen using a 60cc lab-inventory syringe was unable to be successfully completed due to a blocked/clotted injection lumen.Immediate push back on the syringe plunger was experienced.The blockage, most likely dried blood, was unable to be cleared.A lab inventory 0.025in guidewire was back loaded through the distal tip.The guidewire could not advance at approximately 13.7cm from the iabc distal tip, which is the location of the clotted injection lumen.Dried blood was noted on the guidewire upon removal.The guidewire was front loaded through the iabc luer.The guidewire could not advance at approximately 107.1cm from the injection lumen e xtension line luer, which is the location of the clotted injection lumen.Dried blood was noted on the guidewire upon removal.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint that the "wedge catheter would not flush or give hemodynamic reading" is confirmed.During the investigation, the catheter injection lumen aspiration/flushing test was unsuccessful.A blood clot was unable to be cleared from the injection lumen during the guidewire test.The blood built up in the injection lumen may have resulted from not maintaining the patency of the injection lumen.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the blood buildup within the injection lumen.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.

• Brand Name: ARROW CATH PKGD: WEDGE 5 FR 110CM
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23063824
• Report Number: 3010532612-2025-00888
• Device Sequence Number: 21287657
• Product Code: DYG
• UDI-Device Identifier: 00801902002853
• UDI-Public: (01)00801902002853(11)250620(17)261130(10)16F25F0056(21)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: AI-07124
• Device Lot Number: 16F25F0056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2025
• 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
• Patient Sex: Unknown