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

Model Number	401763
Medical Device Problem Codes	Fracture (1260); Inflation Problem (1310); Material Separation (1562)
Health Effect - Clinical Codes	Air Embolism (1697); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Event or Problem 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of air was injected into the balloon.At that time, the sound of a balloon rupture was heard.The balloon was immediately withdrawn after pumping the air back through the syringe.After withdrawal, the balloon was inspected and found to be damaged.The pacemaker implantation was not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.
Additional 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 or Problem Description
There were no patient symptoms, no st elevation and no air was visualized in the patient.
Additional Manufacturer Narrative
Correction: b1, b5, h1, h6.Additional information: 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 remains unknown.
Event or Problem Description
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 aspirating the air back through the syringe.After withdrawal, the balloon was inspected and found to be damaged, and the pacemaker implantation was not successful.The procedure was stopped, and the patient was placed in the left lateral decubitus position and trendelenburg position for oxygen inhalation and enhanced observation.There were no adverse patient consequences.No st elevation occurred, and no air was visualized in the patient.The physician confirmed the detached portion of the balloon was removed during the procedure and discarded.

• Brand Name: PACEL FLOW DIRECTED PACING CATHETER
• Common Device Name: 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14990690
• Report Number: 2182269-2022-00032
• Device Sequence Number: 16614541
• Product Code: LDF
• UDI-Device Identifier: 05414734007856
• UDI-Public: 05414734007856
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K161873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2025

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 11/08/2022; Not provided
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 11/09/2022; 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown