MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE LEAD

Model Number 0672

Device Problems Failure to Capture (1081); Fracture (1260); Mechanical Problem (1384); Contamination /Decontamination Problem (2895); Device Dislodged or Dislocated (2923); Positioning Problem (3009); High Capture Threshold (3266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

The product has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was reported that this right ventricular (rv) lead was not successfully implanted due to helix stopped moving during procedure.Also, this lead was repositioned several times due to lead exhibited high threshold.Also, premature ventricular contraction (pvc) suddenly appeared frequently, and lead was expected to dislodge and confirmed it with fluoroscopy.The ventricle was measured using pacing system analyzer (psa) but it was not detected.In addition, when the helix was checked, a piece of tissue was recognized.Furthermore, physician opinion was that the lead was fractured due to the repeated screwing in and out to position the lead.A new lead was implanted.No adverse patient effects were reported.

Event Description

It was reported that during an implant procedure, this right ventricular (rv) lead was attempted to be implanted, however, high capture thresholds were observed, therefore, it was repositioned several times.After multiple placements, the threshold value stabilized, however, this lead dislodged confirming this by fluoroscopy and loss of capture (loc) was observed.Repositioning was again attempted; however, helix issues were exhibited.The physician opted to remove this lead.Visual inspection noted tissue within the helix.The lead was washed, and the tissue removed, however, the helix was not able to be retracted, therefore, a new lead was implanted.A lead fracture was suspected by the physician.No adverse patient effects were reported.This lead has been received for analysis.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance and inner and outer insulation integrity.Measurements throughout these tests were within normal limits.Visual inspection of the lead found that the helix mechanism was retracted and dried blood/tissue was noted in the helix housing.Visual inspection also showed that the insulation was bunched, and conductor coils were deformed approx., 170-255mm from the terminal end.This is consistent with the lead being placed through a constricted area.This type of damage has been deemed a design issue.

Event Description

It was reported that during an implant procedure, this right ventricular (rv) lead was attempted to be implanted, however, high capture thresholds were observed, therefore, it was repositioned several times.After multiple placements, the threshold value stabilized, however, this lead dislodged confirming this by fluoroscopy and loss of capture (loc) was observed.Repositioning was again attempted; however, helix issues were exhibited.The physician opted to remove this lead.Visual inspection noted tissue within the helix.The lead was washed, and the tissue removed, however, the helix was not able to be retracted.A new lead was implanted.A lead fracture was suspected by the physician.No adverse patient effects were reported.This lead has been received for analysis.

• Brand Name: RELIANCE 4-FRONT
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19039488
• MDR Text Key: 339323216
• Report Number: 2124215-2024-20508
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 225591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 03/14/2024; 05/16/2024
• Supplement Dates FDA Received: 04/12/2024; 05/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2023
• 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 Age: 65 YR
• Patient Sex: Male