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

Catalog Number	AI-07126
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Event or Problem 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 to complete the procedure.No injury to the patient occurred." the patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem 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 to complete the procedure.No injury to the patient occurred." the patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4), the reported complaint of balloon would not inflate in use could not be confirmed as 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 was undetermined.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.
Additional Manufacturer Narrative
Qn# (b)(4).Udi related data quality updates only section d.4.-unique identifier (udi)# corrected to (b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem 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 to complete the procedure.No injury to the patient occurred." the patient status is reported as "fine".

• Brand Name: CATH PKGD: WEDGE 6 FR 110 CM
• Common Device Name: 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18096909
• Report Number: 3010532612-2023-00633
• Device Sequence Number: 12180255
• Product Code: DYG
• UDI-Device Identifier: 00801902002877
• UDI-Public: (01)00801902002877(11)221007(17)240228(10)16F22K0010(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2024
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F22K0010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 12/15/2023; Not provided
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/18/2023; 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.; N/A.
• Patient Sex: Unknown