MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: BERMAN 7 FR 110CM; CATHETER, FLOW DIRECTED

Model Number IPN000085

Device Problem Material Deformation (2976)

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

Event Date 09/30/2022

Event Type  malfunction  

Event Description

The report states that "the balloon inflated asymmetrically during use.Therefore, the catheter was replaced with another kit of the same lot, inserted at the same insertion site to complete the procedure.The user flushed the catheter but did not perform the inflation test before use".No delay in therapy.No report of patient harm or injury.

Manufacturer Narrative

Qn# (b)(4).

Event Description

The report states that "the balloon inflated asymmetrically during use.Therefore, the catheter was replaced with another kit of the same lot, inserted at the same insertion site to complete the procedure.The user flushed the catheter but did not perform the inflation test before use".No delay in therapy.No report of patient harm or injury.

Manufacturer Narrative

(b)(4).The reported complaint that the "balloon inflated asymmetrically during use" 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.The reported complaint will be monitored for any developing trends.Additionally, according to the event details, the user "did not perform the inflation test before use".As a result, an in-service has been requested to review the instructions for use (ifu) with the customer.Other remarks: n/a.Corrected data: n/a.

• Brand Name: CATH PKGD: BERMAN 7 FR 110CM
• 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: 15627146
• MDR Text Key: 306743740
• Report Number: 3010532612-2022-00430
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00801902002297
• UDI-Public: 00801902002297
• 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: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: IPN000085
• Device Catalogue Number: AI-07137
• Device Lot Number: 16F22E0129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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
• Treatment: N/A.; N/A.