MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC 6 FR 90 CM BALLOON WEDGE PRESSURE CATHETER; CATHETER, FLOW DIRECTED

Model Number	IPN000073
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	02/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#: (b)(4).There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.
Event or Problem Description
It was reported that cardiac tamponade occurred during the procedure with a balloon catheter due to the pressure applied with the catheter into the coronary sinus.An urgent cardiac surgery was required.According to follow-up information received, the patient is still in the hospital, but improving.
Event or Problem Description
It was reported that cardiac tamponade occurred during the procedure with a balloon catheter due to the pressure applied with the catheter into the coronary sinus.An urgent cardiac surgery was required.According to follow-up information received, the patient is still in the hospital, but improving.
Additional Manufacturer Narrative
(b)(4).The product was not returned for investigation.The reported complaint of catheter difficult to advance in patient is not able to be confirmed.The root cause of the complaint is undetermined.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.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.

• Brand Name: 6 FR 90 CM BALLOON WEDGE PRESSURE CATHETER
• 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: kaylia pen ; 16 elizabeth drive; chelmsford, MA 01824
• MDR Report Key: 13903036
• Report Number: 3010532612-2022-00100
• Device Sequence Number: 4303233
• Product Code: DYG
• UDI-Device Identifier: 00801902004468
• UDI-Public: 00801902004468
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: IPN000073
• Device Catalogue Number: AI-07126-J
• Device Lot Number: 16F21G0089
• 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: 02/24/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.; NI.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown