MAUDE Adverse Event Report: ST. JUDE MEDICAL PACEL FLOW DIRECTED PACING CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 401763

Device Problems Fracture (1260); Inflation Problem (1310)

Patient Problem Air Embolism (1697)

Event Date 05/11/2022

Event Type  Injury  

Event Description

This per is initiated from an adverse incident report submitted by (b)(6) hospital of (b)(6) directly to china medical device ae reporting system (http://maers.Adrs.Org.Cn).The sjm notified was made aware on (b)(6) 2022 from the system.Please provide the final rr details per wi 87835.The nmpa report is due aug 26, 2022.On (b)(6) 2022, the patient underwent a temporary cardiac pacemaker implant.The operator connected the tail end of the balloon catheter with the equipped syringe.After in vitro inspection, the balloon was free of an air leak.The balloon catheter was then advanced through the sheath.After approximately 20 cm had been delivered, 1ml of air was injected into the balloon.At that time, the sound of a balloon rupture was heard.The balloon was immediately withdrawn after pumping the air back through the syringe.After withdrawal, the balloon was inspected and found to be damaged.The pacemaker implantation was not successful and a possible air embolism occurred in the venous system.The procedure was stopped immediately and the patient was placed in the left lateral decubitus position and trendelenburg position for oxygen inhalation and enhanced observation.Presently, there are no effects to the patient.

Manufacturer Narrative

Additional information: b5, d9, g3, h2, h3.One 5f pacel bipolar pacing catheter (flow direct) was received for evaluation.The results of the investigation concluded that the balloon material had been torn at both the proximal end and distal end; the medial section had detached and was not returned.The distal and proximal balloon adhesive bonds remained intact.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the inflation difficulty is consistent with the balloon tears.The cause of the balloon tears remain unknown.

Event Description

There were no patient symptoms, no st elevation and no air was visualized in the patient.

• Brand Name: PACEL FLOW DIRECTED PACING CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14990690
• MDR Text Key: 295764765
• Report Number: 2182269-2022-00032
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 05414734007856
• UDI-Public: 05414734007856
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K161873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 401763
• Device Catalogue Number: 401763
• Device Lot Number: 8095796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 07/12/2022
• Supplement Dates Manufacturer Received: 11/08/2022
• Supplement Dates FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other