MAUDE Adverse Event Report: ST. JUDE MEDICAL PACEL PATIENT CABLE; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number 401695

Device Problem No Pacing (3268)

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762)

Event Date 07/04/2019

Event Type  Injury  

Event Description

After placing a pacing catheter in the patient's heart chamber and connecting it to an external pacemaker using the first-use extension cable, the catheter stopped pacing intermittently during the procedure and cardiac arrest was temporarily caused.The intermittent pacing issue was resolved by removing the cable and connecting the catheter directly to the external pacemaker and the procedure was completed with no adverse consequences for the patient.

Manufacturer Narrative

One pacel patient cable was returned to the manufacturer for analysis.The reported event of an ¿intermittent pacing issue¿ was confirmed.The results of the investigation concluded there was an intermittently open circuit between the red ¿(+)¿ connector pin and ¿+¿ socket.Microscopic inspection revealed the cable had been damaged; the wire insulation had been twisted within the red ¿(+)¿ strain relief and appeared torn; it was also noted that the wire insulation had been torn within the black (-) strain relief.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the intermittent open circuit is consistent with the cable damage.The cause of the cable damage is consistent with damage during use.

Manufacturer Narrative

One pacel patient cable was returned to the manufacturer for analysis.The reported event of an ¿intermittent pacing issue¿ was confirmed.The results of the investigation concluded there was an intermittently open circuit between the red ¿(+)¿ connector pin and ¿+¿ socket.Microscopic inspection revealed the cable had been damaged; the wire insulation had been twisted within the red ¿(+)¿ strain relief and appeared torn; it was also noted that the wire insulation had been torn within the black (-) strain relief.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the intermittent open circuit is consistent with cable damage.

Manufacturer Narrative

Additional information revealed the initial mdr for this event was reported under the incorrect mfr report # and manufacturing site.Corrected manufacturing site information has been provided in manufacturing site.The correct mfr number is 2182269.

• Brand Name: PACEL PATIENT CABLE
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8799002
• MDR Text Key: 151326487
• Report Number: 3005334138-2019-00389
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• PMA/PMN Number: K910645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/09/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 401695
• Device Lot Number: 6687731
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 08/06/2019; 08/06/2019; 08/06/2019
• Supplement Dates FDA Received: 08/23/2019; 09/24/2019; 04/09/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention