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

Catalog Number AI-07126

Device Problem Difficult to Advance (2920)

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

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

The report states "today during a procedure my surgeon opened a new balloon wedge pressure catheter that we just ordered last month.A tip deflector 0.035" wire was inserted into the 6f bwp (which we have done before).The tip deflector became lodged and difficult to maneuver within the bwp.Upon investigating the bwp, there was a tear in the bwp at the top just before the bifurcation of the balloon and flush ports.It seemed that the bwp ripped and created friction making it difficult to remove the tip deflector".Additional information received states that the tip deflector was able to be successfully removed from the patient.A new catheter was inserted at the same insertion site.There was no patient harm or injury.The patient status is reported as "recovered well from the procedure".

Event Description

The report states "today during a procedure my surgeon opened a new balloon wedge pressure catheter that we just ordered last month.A tip deflector 0.035" wire was inserted into the 6f bwp (which we have done before).The tip deflector became lodged and difficult to maneuver within the bwp.Upon investigating the bwp, there was a tear in the bwp at the top just before the bifurcation of the balloon and flush ports.It seemed that the bwp ripped and created friction making it difficult to remove the tip deflector".Additional information received states that the tip deflector was able to be successfully removed from the patient.A new catheter was inserted at the same insertion site.There was no patient harm or injury.The patient status is reported as "recovered well from the procedure".

Manufacturer Narrative

Qn#(b)(4) the reported complaint of catheter difficult to advance in 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.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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18302021
• MDR Text Key: 330176852
• Report Number: 3010532612-2023-00717
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00801902002877
• UDI-Public: 00801902002877
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K892530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AI-07126
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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