MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: BERMAN 6 FR 90CM; CATHETER, FLOW DIRECTED

Catalog Number AI-07136

Device Problem Inflation Problem (1310)

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

Event Date 03/03/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported " the balloon did not inflate during use on a patient.Therefore, the catheter was removed and replaced with another kit, and completed the procedure.No harm to the patient was reported.The balloon inflated without any problems during the pre-procedural in vitro inflation test and the initial in-vivo inflation." the customer is not able to confirm if the second cather was was inserted into the same insertion site.Patient's current condition reported as "fine".

Manufacturer Narrative

Qn#(b)(4) the reported complaint that the "balloon did not inflate during use on a patient" is not able to be confirmed.The product was not returned for investigation.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.The reported complaint will be monitored for any developing trends.

Event Description

It was reported " the balloon did not inflate during use on a patient.Therefore, the catheter was removed and replaced with another kit, and completed the procedure.No harm to the patient was reported.The balloon inflated without any problems during the pre-procedural in vitro inflation test and the initial in-vivo inflation." the customer is not able to confirm if the second cather was was inserted into the same insertion site.Patient's current condition reported as "fine".

• Brand Name: CATH PKGD: BERMAN 6 FR 90CM
• 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: 18950398
• MDR Text Key: 338252117
• Report Number: 3010532612-2024-00211
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00801902002280
• UDI-Public: 00801902002280
• 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,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: AI-07136
• Device Lot Number: 16F23B0024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2023
• 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