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

Model Number IPN923527

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "during the procedure according to ifu, md found that the balloon did not swell during the procedure.So md opened up the new kit to finish the procedure." no patient harm or injury.The patient status is reported as "fine".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.

Event Description

It was reported that "during the procedure according to ifu, md found that the balloon did not swell during the procedure.So md opened up the new kit to finish the procedure." no patient harm or injury.The patient status is reported as "fine".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.

Manufacturer Narrative

(b)(4).The reported lot number (16f22l0056) matches the lot number on the returned original packaging pouch/label.Returned for investigation was a 6fr.110cm wedge catheter with the original packaging pouch.The sample was returned in the ups shipping box and was in a sealed ziploc bag.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 1.0cc.The supplied control stroke syringe was not returned with the sample.Upon microscopic inspection, the balloon appeared typical; no damage or abnormalities were noted to the balloon.Spots of dried white substance were noted in the injection lumen extension line.No condensation was noted within the inflation lumen extension line.No blood was noted on the interior or the exterior surfaces of the returned catheter.No visual damage or abnormalities were noted to the returned sample.The inflation lumen was injected with 1.0cc of air using a lab inventory control stroke syringe.The balloon inflated symmetrically.One side of the balloon measured approximately 5mm.The other side measured approximately 5mm.The balloon did meet specifications per graphic i-07126-007e rev.00 of radius ratio less than or equal to 1.5.The inflation lumen was injected with 1.0cc of air using a lab inventory control stroke syringe.The balloon inflated symmetrically.The balloon deflated in less than 3 seconds when the syringe was removed per specification i-07126-007e rev.00.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.Some dried blood exited.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 lumen extension line luer.No resistance was noted; 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 "balloon did not swell during the procedure" is not confirmed.During the investigation, the balloon inflated as per specifications.The returned device passed visual and functional test specifications.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.Other remarks: n/a.Corrected data: n/a.

• Brand Name: CATH PKGD: WEDGE 6 FR 110 CM
• Type of Device: 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: 17291573
• MDR Text Key: 318892382
• Report Number: 3010532612-2023-00377
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 10801902206746
• UDI-Public: 10801902206746
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K892530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: IPN923527
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F22L0056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1