MAUDE Adverse Event Report: ETHICON, LLC ETHICON 2-0 MULTIFILAMENT STAINLESS STEEL; ELECTRODE, PACEMAKER, TEMPORARY

Model Number TPW32

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/26/2020

Event Type  Injury  

Event Description

An infant male patient required cardiac surgery for atrial septal defect (asd) closure (primary) and pulmonary valvectomy with placement of transannular autologous pericardial patch on [date redacted].Post-operatively, the patient required cpr with 8 minutes of chest compressions.Cardiac surgery indicated that they thought the compressions caused the internal portion of one of the ventricular pacing wires to kink or fracture.The wires were removed in the picu 2 weeks later by nurse practitioner (np) under the supervision of an md.There was no reported resistance at the time of removal.A subsequent x-ray showed a retained wire fragment where the internal kinking appears to have occurred on x-ray.The cardiac pacing wire broke either during compressions or was weakened during cpr and then broke fully during removal.Given the child's medical status at the time, the cardiac surgery team decided to leave the wire fragment in the patient for potential removal at a later date.The child is doing well, but may need additional procedures in the future when cardiac surgery could potentially remove the wire fragment.The team placed an mri alert in the medical record and is following the patient.The inability to use mri on this patient has affected care for other medical conditions.It is unclear what the long term outcome will be at this point.

• Brand Name: ETHICON 2-0 MULTIFILAMENT STAINLESS STEEL
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ETHICON, LLC; highway 183 km. 8.3; san lorenzo PR 00754
• MDR Report Key: 10626240
• MDR Text Key: 209779967
• Report Number: 10626240
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TPW32
• Device Catalogue Number: TPW32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 210 DA
• Patient Weight: 6