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

Model Number 439688

Device Problem Device Handling Problem (3265)

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

Event Date 11/03/2014

Event Type  malfunction  

Event Description

It was reported that a left ventricular (lv) lead was attempted/not used due to the physician was unable to pass a competitors guidewire all the way through the lead.The lead was removed and a new lead was placed using the same guidewire.Once the second lead was placed the physician had difficulty removing the guidewire, which had apparently become stuck in the lead lumen.The physician was able to remove the guidewire and the lead remains in use.It was also noted that the physician had difficulty inserting a guidewire through the verogram balloon.The same guidewire was utilized with a new venogram balloon without incident.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the full lead was returned and analyzed.Analysis indicated the distal conductor was extrinsically distorted due to kinking/buckling.The proximal conductor of the lead became extrinsically distorted due to kinking/buckling, the information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

• Brand Name: ATTAIN ABILITY STRAIGHT
• 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): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4496977
• MDR Text Key: 5441170
• Report Number: 2649622-2015-00547
• Device Sequence Number: 1
• Product Code: OJX
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2014

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: Physician
• Device Expiration Date: 03/13/2015
• Device Model Number: 439688
• Device Catalogue Number: 439688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2014
• Initial Date FDA Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2013
• 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
• Treatment: 4641, COMPETITOR ACUITY WHISPER VIEW GUIDEWIRE
• Patient Age: 00061 YR