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

Model Number IPN923527

Device Problem Leak/Splash (1354)

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

Event Date 12/23/2022

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, [physician] found balloon ruptured, so [physician] opened up a new kit to finish the procedure".Additional information states that the second catheter was inserted at the same insertion site.No report of patient harm or injury.No medical intervention needed.The patient condition is reported as "fine".

Event Description

It was reported that "during the procedure according to ifu, [physician] found balloon ruptured, so [physician] opened up a new kit to finish the procedure".Additional information states that the second catheter was inserted at the same insertion site.No report of patient harm or injury.No medical intervention needed.The patient condition is reported as "fine".

Manufacturer Narrative

Qn # (b)(4).The reported lot number (16f22f0029) matches the lot number on the returned original packaging pouch.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 returned syringe.The inflation lumen stopcock was in the open position.The recommended volume capacity of the balloon is 1.0cc.Upon microscopic inspection, the catheter balloon was immediately noted ruptured/torn; the balloon was ruptured/torn approximately 0.2cm to 0.5cm from the distal tip of the catheter.No contrast media was noted in the injection lumen extension line.No condensation was noted in the inflation lumen extension line.Spots of dried blood were noted on the exterior surfaces of the returned sample.No blood was noted within the interior surfaces of the returned sample.No other damage or abnormalities were noted to the returned sample.The symmetry of the balloon could not be measured due to the returned state of the device.The balloon could not be functionally tested due to the returned state of the device.The balloon damage was previously confirmed near the distal tip of the catheter.The cause of the ruptured/torn balloon cannot be determined.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.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 risk is acceptable.This will be monitored for any developing trends.The reported complaint of balloon leak/rupture in use is confirmed.The catheter balloon was found ruptured/torn upon receipt of the sample.The cause of the rupture/torn balloon could not be confidently determined.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 ruptured/torn balloon.The root cause of the complaint 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
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16183876
• MDR Text Key: 308859628
• Report Number: 3010532612-2023-00030
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: IPN923527
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F22F0029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1