MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: WEDGE 4 FR 60CM; CATHETER, FLOW DIRECTED

Model Number IPN923524

Device Problem Material Deformation (2976)

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

Event Date 03/07/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4), n/a, other remarks: n/a, corrected data: n/a.

Event Description

It was reported that "the balloon inflated asymmetrically during use.Therefore, the user removed the catheter and opened a new kit but the same issue occurred during the inflation test, consecutively to three kits in total.So, the fifth kit was used, inserted at the same insertion site with the first one to complete the procedure".No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that "the balloon inflated asymmetrically during use.Therefore, the user removed the catheter and opened a new kit but the same issue occurred during the inflation test, consecutively to three kits in total.So, the fifth kit was used, inserted at the same insertion site with the first one to complete the procedure".No patient harm or injury.The patient status is reported as "fine.".

Event Description

It was reported that "the balloon inflated asymmetrically during use.Therefore, the user removed the catheter and opened a new kit but the same issue occurred during the inflation test, consecutively to three kits in total.So, the fifth kit was used, inserted at the same insertion site with the first one to complete the procedure".No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).The reported lot number (16f22g0071) matches the lot number on the returned original packaging label.Returned for investigation was a 4fr.Wedge 60cm 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 pouch.Upon return, the supplied control stroke syringe was 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 0.60cc.Upon 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 within injection lumen extension line.No blood was noted on the interior or the exterior surfaces of the returned sample.No visual damage or abnormalities were noted to the returned sample.The inflation lumen was injected with 0.60cc of air using the returned control stroke syringe.The balloon inflated asymmetrically.One side of the balloon measured approximately 4.5mm.The other side measured approximately 2.5mm.The balloon did meet specifications.The inflation lumen was injected with 0.60cc of air using the returned control stroke syringe.The balloon inflated asymmetrically.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.The catheter's injection lumen was aspirated and flushed.No abnormalities or debris were 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 inflated asymmetrically during use" is confirmed; however, the balloon met dimensional specifications.The returned device passed functional and dimensional testing.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.The reported complaint will be monitored for any developing trends.No further action required at this time.

• Brand Name: CATH PKGD: WEDGE 4 FR 60CM
• 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: 16538905
• MDR Text Key: 311573515
• Report Number: 3010532612-2023-00163
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 10801902206715
• UDI-Public: 10801902206715
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: IPN923524
• Device Catalogue Number: AI-07121
• Device Lot Number: 16F22G0071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2022
• 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