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

Model Number 419688

Device Problems Failure to Capture (1081); Fracture (1260); Device Contamination with Body Fluid (2317); Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)

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

Event Date 04/04/2019

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, while testing the left ventricular (lv) threshold, there was no capture at high output.I look at the fluoroscopy noted the lead had pulled back slightly.The physician disconnected the lv lead and tried put a guidewire through the lead to provide stability.The wire would not advance in the inner lune of the lead very far.Physician noted blood in or on the insulation of the lead where the wire would not pass.Physician then flushed the lead with saline using a sub-dermal needle and noted that the saline was leaking out where the wire was getting held up.The physician cut the lead just proximal to the apparent insulation issue.The physician reinserted the guidewire through the lead was able to successfully place it into the coronary sinus (cs) and maintain venous access while removing the lead lv lead.It was also noted there possible fracture.The lead lv lead was attempted and not used.A different lv lead was used to complete the procedure.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the full lead was returned in segments, analyzed.Analysis indicated that the distal conductor was extrinsically distorted due to kinking/buckling.The proximal conductor of the lead became extrinsically distorted due to kinking/buckling.The outer insulation of the lead was extrinsically breached due to a cut.Visual analysis of the lead indicated damage during use.The analyst noted that visual inspection found the conductors were kinked, and the insulation was cuts.It looks likely that conductor kink occured when the anchoring sleeve tied down during implant.After the lead was placed and dislodged, the insulation could be cut during re-position the lead.According to the reported and the analysis results, it is likely that after the lead was placed and dislodged, when try to re-position the lead, the guidewire could not go through because the conductors were kinked, and the solution saline was leaking out due to the insulation breached.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN ABILITY
• 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8555631
• MDR Text Key: 143261688
• Report Number: 2649622-2019-07118
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169860032
• UDI-Public: 00643169860032
• 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,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2019
• Device Model Number: 419688
• Device Catalogue Number: 419688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2017
• 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: 64 YR
• Patient Weight: 80