MAUDE Adverse Event Report: MPRI ATTAIN STABILITY QUAD MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 479888

Device Problems Material Too Rigid or Stiff (1544); Device Contamination with Body Fluid (2317)

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

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the implant procedure, the lumen of the lead was contaminated with blood resulting in the formation of a ¿blood clot¿, which made the guidewire manipulation difficult.It was noted that the lead and guidewire was removed, the appearance was checked, and the guidewire was thoroughly cleaned with heparin water.Implantation was performed again, but the physician felt that the guidewire manipulation was stiff when ¿connecting with the tip of the lead¿.A new guidewire was used and wet thoroughly with heparin water.The guidewire was inserted into the lumen of the lead and the issue persisted.The lead was removed, and a flush was performed, but was not possible because the saline did not come out from the tip of the lead.The saline came back to the proximal side of the lead.The lead was not used, and another lead was implanted.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN STABILITY QUAD MRI SURESCAN
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 11003470
• MDR Text Key: 221291732
• Report Number: 2649622-2020-24420
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2020

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: Lay User/Patient
• Device Expiration Date: 11/06/2022
• Device Model Number: 479888
• Device Catalogue Number: 479888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/14/2020
• Date Device Manufactured: 11/17/2020
• 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: 71 YR