MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: WEDGE 6 FR 110 CM; CATHETER, FLOW DIRECTED

Catalog Number	AI-07126
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "it was reported that the lumen was flushed without problem.However, when the user inserted a guidewire through the catheter, it stopped on the way and could not be advanced further.The user replaced the catheter with another one, but the same issue occurred.No injury to the patient was reported".A third catheter was inserted to continue therapy.The patient's current condition is "unknown".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.Please see associated mdr# 3010532612-2025-00009.
Additional Manufacturer Narrative
(b)(4).The lot number reported is 16f24f0046.The lot number of the returned device is suspected to be from the reported lot; however, no original packaging/lid stock was returned.Returned for investigation was a 6fr.Wedge 110cm catheter without its original packaging.The sample was returned in the ups shipping box and was in ziploc bag.Upon return, a non-teleflex 0.035in guidewire was inserted within the injection lumen and a section of the guidewire remained exposed; no kinks/bends or abnormalities were noted to the exposed section of the returned guidewire.The inflation lumen stopcock was in the open position.The supplied control stroke syringe was noted connected to the inflation lumen stopcock; no visual damage or abnormalities were noted to the returned syringe.The recommended volume capacity of the balloon is 1.0cc.Under microscopic inspection, the balloon appeared typical; no damage or abnormalities were noted to the balloon.No condensation was noted in the inflation lumen extension line.No contrast media was noted in the injection lumen extension line.No blood was noted on the interior or the exterior surfaces of the returned catheter.The infla-tion lumen was injected with 1.0cc of air using the returned control stroke syringe.The balloon inflated symmetrically.One side of the balloon measured approximately 4mm.The other side measured approximately 4mm.The balloon did meet specifications per graphic of radius ratio less than or equal to 1.5.The diameter of the returned non-teleflex guidewire measured 0.033".The non-teleflex 0.035in guidewire was removed from the catheter while experiencing resistance.The re-turned 0.035in guidewire was back loaded through the distal tip.Resistance was noted upon loading the guidewire.The guidewire was able to advance through the injection lumen.No blood or debris was noted.Upon further inspection, it was determined that the guidewire material/coating properties were causing the resistance.A lab inventory 0.035in and 0.025in guidewire were back loaded through the distal tip.No resistance was noted using either guidewire; each guidewire was able to advance through the injection lumen.No blood or debris was noted.The injection lumen was successfully aspirated and flushed.No blood or debris was noted.The inflation lumen was injected with 1.0cc of air using the returned control stroke syringe.The balloon inflated symmetrically.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.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 for "inserted a guidewire through the catheter, it stopped on the way and could not be advanced further" is not confirmed.During the investigation, the catheter passed visual and functional testing; no problem was found with the returned sample.However, the 0.035in non-teleflex guidewire returned with the device was unable to pass freely through the catheter.Resistance was observed due to the material/ coating properties of the guidewire.A lab inventory 0.035in and 0.025in guidewire were tested with the catheter and each guidewire passes freely with no resistance.Based on a review of the device history record (dhr), the product met specification upon release.The probable root cause of the complaint is related to the coating of the non-telefex guidewire.No further action required at this time.
Event or Problem Description
It was reported "it was reported that the lumen was flushed without problem.However, when the user inserted a guidewire through the catheter, it stopped on the way and could not be advanced further.The user replaced the catheter with another one, but the same issue occurred.No injury to the patient was reported".A third catheter was inserted to continue therapy.The patient's current condition is "unknown".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.Please see associated mdr# 3010532612-2025-00009.

• Brand Name: CATH PKGD: WEDGE 6 FR 110 CM
• 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: 21057053
• Report Number: 3010532612-2025-00011
• Device Sequence Number: 8136847
• Product Code: DYG
• UDI-Device Identifier: 00801902002877
• UDI-Public: (01)00801902002877(11)240628(17)251130(10)16F24F0046(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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
• Device Expiration Date: 11/30/2025
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F24F0046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• 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