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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that "during the procedure according to ifu, md found that catheters do not enter along guide wire.So md opened up the new kit to finish the procedure".No patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
It was reported that "during the procedure according to ifu, md found that catheters do not enter along guide wire.So md opened up the new kit to finish the procedure".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported lot number (16f23c0055) matches the lot number on the returned packaging.Returned for investigation was a 6fr.110cm wedge catheter with the original packaging pouch.Upon return, the supplied control stroke syringe was noted connected to the inflation lumen stopcock; no damage or abnormalities were noted to the syringe.The inflation lumen stopcock was in the open position.The recommended volume capacity of the balloon is 1.0cc.Under microscopic inspection, the balloon appeared typical; no abnormalities were noted to the balloon surface.Upon further inspection, the catheter body was noted with flattened surfaces at two different locations from approximately 68.3cm to 68.7cm and 83.3cm to 83.5cm from the distal tip of the catheter.No condensation was noted in the inflation lumen extension line.No contrast media was noted within the injection lumen extension line.Dried blood was noted on the exterior surfaces of the returned sample.No blood was noted within the interior surfaces of the returned sample.The inflation 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 5mm.The other side measured approximately 5mm.The balloon did not meet specifications of radius ratio less than or equal to 1.5.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.Upon tug test, no pull away was noted.The balloon was placed in water, and air was injected into the inflation lumen again.No leak was noted.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 of the catheter.Resistance was noted at approximately 68.3cm and 83.3cm from the distal tip of the catheter, which are the locations of the previously noted flattened surfaces on the catheter body.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 luer.Resistance was noted at approximately 38.2cm and 53cm from the injection extension luer, which are the locations of the previously noted flattened surfaces on the catheter body.The guidewire was able to advance through the injection lumen.No blood or debris 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 that the "catheter do not enter along guide wire" is confirmed.Upon visual inspection , the catheter body was noted with a flattened surface.Upon inserting a guidewire through the catheter , resistance was experienced at the locations of the flattened surface noted on the catheter body.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 damaged/flattened catheter body.The root cause of the damaged/flattened catheter body is undetermined.No further action required at this time.This will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18439722
• Report Number: 3010532612-2024-00014
• Device Sequence Number: 17880165
• Product Code: DYG
• UDI-Device Identifier: 00801902002877
• UDI-Public: 00801902002877
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2023

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: 08/31/2024
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F23C0055
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2023
• 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