MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CATH PKGD: WEDGE 5 FR 60CM; CATHETER, FLOW DIRECTED

Catalog Number	AI-07124
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " during the procedure according to ifu, the md found the balloon could not pass following the wire.So the md opened up the new kit to finish the procedure." no patient injury or consequence reported.Patient condition reported as "fine".
Event or Problem Description
It was reported " during the procedure according to ifu, the md found the balloon could not pass following the wire.So the md opend up the new kit to finish the procedure." no patient injury or consequence reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).Returned for investigation was a 5fr.Wedge 110cm catheter with its original packaging pouch.The sample was loosely packed within the original packaging tray.Upon return, the inflation lumen stopcock was in the open position.The recommended volume capacity of the balloon is 0.75cc.The supplied control stroke syringe was not returned with the sample.Upon microscopic inspection, stress marks were visible on the balloon surface.Additionally, evidence of dried liquid/contrast media was noted within the interior surfaces of the balloon.Dried liquid/contrast media was noted in the inflation lumen extension line.No liquid/contrast media was noted within the injection lumen extension line.No blood was noted on the interior or the exterior surfaces of the returned sample.Upon further inspection, no blockage or abnormalities were noted to the distal tip of the catheter.No kink, bend or flattened surface was noted on the returned catheter extrusion/body.No other damage or abnormalities were noted to the returned sample.Since the returned state of device provided enough evidence of using liquid for the balloon inflation, an in-service has been requested.The instructions for use (ifu) states: "liquids must not be used as balloon inflation media.The small diameter of the inflation lumen may make it impossible to completely inflate or deflate a liquid-filled balloon.In addition, inflating the balloon with liquid reduces the ability of the catheter to flow with the circulation." per the ifu for testing balloon integrity before use, "fill the syringe with the amount of inflation medium recommended for the catheter being used.Warning: do not exceed the maximum inflation capacity of the balloon as indicated on the pigtail of the pressure lumen and in the separate instruction insert.Carbon dioxide must be used if there is a possibility that balloon rupture would result in air embolism in the left heart or systemic circulation." the balloon did not inflate due to the blocked inflation lumen; therefore, the symmetry of the balloon could not be measured.The injection lumen was aspirated and flushed.No blood or debris was noted.A lab inventory 0.025in guidewire was back loaded through the distal tip.No resistance was noted; the guidewire was able to advance through the injection lumen.No blood or debris was noted.The guidewire was front loaded through the injection extension line.No resistance was noted; the guidewire was able to advance through the injection lumen.No blood or debris was noted.The inflation lumen was injected with 0.75cc of air using a lab inventory control stroke syringe and push back was immediately noted to the returned syringe plunger.The balloon did not inflate due to a blocked inflation lumen.Dried liquid/contrast media was previously confirmed within the interior surfaces of the balloon/inflation lumen extension line.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 "balloon could not pass following the wire" is not confirmed.During the investigation, no blockage or abnormalities were noted to the distal tip of the catheter and the injection lumen.The guidewire was able to advance through the injection lumen without any difficulty.The returned device passed visual and functional test specifications for the reported event.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.Unrelated to the reported complaint, the returned state of device provided enough evidence of using liquid for the balloon inflation.As a result, an in-service has been requested to reiterate the instructions for use, including the appropriate method for testing balloon integrity before use.

• Brand Name: ARROW CATH PKGD: WEDGE 5 FR 60CM
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18672745
• Report Number: 3010532612-2024-00116
• Device Sequence Number: 6144231
• Product Code: DYG
• UDI-Device Identifier: 00801902002846
• UDI-Public: 00801902002846
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: AI-07124
• Device Lot Number: 16F22F0033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• 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: N/A.; N/A.
• Patient Sex: Unknown