MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: BERMAN 7 FR 110CM; CATHETER, FLOW DIRECTED

Catalog Number	AI-07137
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the balloon got ruptured during the procedure.Therefore, the user replaced the catheter with a new one.No patient injury was reported".The 2nd catheter was inserted at the same insertion site.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
Qn# (b)(4).The reported complaint that the "balloon got ruptured during the procedure" 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.
Event or Problem Description
It was reported that "the balloon got ruptured during the procedure.Therefore, the user replaced the catheter with a new one.No patient injury was reported".The 2nd catheter was inserted at the same insertion site.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Section d.4.-unique identifier (udi)# corrected to (b)(4).
Event or Problem Description
It was reported that "the balloon got ruptured during the procedure.Therefore, the user replaced the catheter with a new one.No patient injury was reported".The 2nd catheter was inserted at the same insertion site.The patient status is reported as "fine".

• Brand Name: CATH PKGD: BERMAN 7 FR 110CM
• 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, NC 27560
• MDR Report Key: 17890040
• Report Number: 3010532612-2023-00570
• Device Sequence Number: 6995149
• Product Code: DYG
• UDI-Device Identifier: 00801902002297
• UDI-Public: (01)00801902002297(11)220531(17)230930(10)16F22E0129(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): 09/21/2023

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: 09/30/2023
• Device Catalogue Number: AI-07137
• Device Lot Number: 16F22E0129
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 11/07/2023; Not provided
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 11/07/2023; 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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