MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: BERMAN 5 FR 80CM; CATHETER, FLOW DIRECTED

Model Number	IPN923529
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter near the balloon got broken during the procedure, probably because the contrast agent flowed into the balloon.Therefore, the catheter was replaced through the same site with a new one.No harm to the patient was reported and no other medical intervention was required.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that the catheter near the balloon got broken during the procedure, probably because the contrast agent flowed into the balloon.Therefore, the catheter was replaced through the same site with a new one.No harm to the patient was reported and no other medical intervention was required.

• Brand Name: CATH PKGD: BERMAN 5 FR 80CM
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16034301
• Report Number: 3010532612-2022-00541
• Device Sequence Number: 15260079
• Product Code: DYG
• UDI-Device Identifier: 10801902206654
• UDI-Public: 10801902206654
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2022

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: 10/31/2023
• Device Model Number: IPN923529
• Device Catalogue Number: AI-07135
• Device Lot Number: 16F22F0052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown