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

Model Number	IPN923525
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
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.The replaced catheter inflated without problem and the procedure was completed".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(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.The replaced catheter inflated without problem and the procedure was completed".No patient harm or injury.The patient status is reported as "fine".
Additional 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
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17111886
• Report Number: 3010532612-2023-00307
• Device Sequence Number: 2188784
• Product Code: DYG
• UDI-Device Identifier: 10801902206722
• UDI-Public: 10801902206722
• 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
• Report Date (Section B): 05/23/2023

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2022
• 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
• Patient Sex: Unknown