MAUDE Adverse Event Report: MPRI ATTAIN PERFORMA; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 429878

Device Problems Deformation Due to Compressive Stress (2889); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/12/2018

Event Type  malfunction  

Manufacturer Narrative

The full lead was returned and analyzed.Analysis indicated that there was blood on the distal conductor of the lead and it was obstructed.The analyst noted that the guidewire insertion test was performed, the guidewire could not insert by back loading from the distal end due to dried blood obstructed visible inside the lead tip nose.Then, inserted the guidewire through the is-4 pin.The guidewire passed through the coil lumen to the distal tip and was obstructed by blood at the tip nose, and could not get throughout the lead distal end.There was no obstruction inside the coil lumen, excepted blood in tip nose.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the implant procedure, the left ventricular (lv) lead was in the vessel with the guidewire out in front of the lead and when trying to advance the lead over the guidewire, the lead started to buckle and there was trouble pulling the guidewire back into the lead.The guidewire became stuck in the lv lead and there was difficulty getting the wire out.The lv lead was replaced.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN PERFORMA
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7414706
• MDR Text Key: 105151472
• Report Number: 2649622-2018-03585
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601826
• UDI-Public: 00643169601826
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2019
• Device Model Number: 429878
• Device Catalogue Number: 429878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2017
• 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: 40 YR