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

Catalog Number	AI-07127
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use "the balloon popped as the staff were inflating it".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn # (b)(4).Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4), additional information received on 13 dec 2023 states that the catheter was removed and a 2nd catheter was inserted at the same insertion site.No patient harm or injury.The patient status is reported as stable.The reported complaint that the "balloon popped as the staff were inflating it" 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.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that during use "the balloon popped as the staff were inflating it".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Event or Problem Description
It was reported that during use "the balloon popped as the staff were inflating it".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
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.

• Brand Name: CATH PKGD: WEDGE 7 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, NC 27560
• MDR Report Key: 18182044
• Report Number: 3010532612-2023-00681
• Device Sequence Number: 15366859
• Product Code: DYG
• UDI-Device Identifier: 00801902002884
• UDI-Public: (01)00801902002884(11)230509(17)240930(10)16F23E0004(21)
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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: 09/30/2024
• Device Catalogue Number: AI-07127
• Device Lot Number: 16F23E0004
• 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: 11/21/2023
• Supplement Report FDA Received Date: 12/15/2023; 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2023
• 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