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	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "balloon puncture, failure".Additional information status that this issue happened prior to use.No patient involvement.Another catheter was used to begin the procedure.
Event or Problem Description
It was reported "balloon puncture, failure".Additional information status that this issue happened prior to use.No patient involvement.Another catheter was used to begin the procedure.
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint for "balloon puncture" 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.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19261610
• Report Number: 3010532612-2024-00344
• Device Sequence Number: 6519448
• Product Code: DYG
• UDI-Device Identifier: 00801902002877
• UDI-Public: 00801902002877
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F2B0001
• 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: 04/11/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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