MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: WEDGE 5 FR 60CM; CATHETER, FLOW DIRECTED

Model Number IPN923525

Device Problem Inflation Problem (1310)

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

Event Date 05/22/2023

Event Type  malfunction  

Event Description

It was reported that "the balloon inflated normally during the inflation test before use.However, it did not inflate enough after the catheter was inserted into the patient.Therefore, it was removed and replaced with a new kit of the same lot, inserted at the same insertion site.The replaced catheter inflated without problem and the procedure was completed".No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the balloon inflated normally during the inflation test before use.However, it did not inflate enough after the catheter was inserted into the patient.Therefore, it was removed and replaced with a new kit of the same lot, inserted at the same insertion site.The replaced catheter inflated without problem and the procedure was completed".No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The reported complaint that the balloon "did not inflate enough" is not able to be confirmed.The product was not returned for investigation.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 root cause of the complaint could not be determined.The reported complaint will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.

• Brand Name: CATH PKGD: WEDGE 5 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17111886
• MDR Text Key: 317217623
• Report Number: 3010532612-2023-00307
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 10801902206722
• UDI-Public: 10801902206722
• 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
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: IPN923525
• Device Catalogue Number: AI-07123
• Device Lot Number: 16F22H0071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2022
• 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