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

Model Number 459888

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

Continuation of medical devices: 6250eh catheter: (b)(6) 2018;.035 wholey competitor guidewire: (b)(6) 2018; 6232adj slitter: (b)(6) 2018; 9fr 13cm optiseal introducer: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during implant attempt, the physician back-loaded the lead over a competitor guidewire.After the lead had been seated deeply into a lateral vein in an acceptable location, the physician attempted to remove the guidewire but it would not retract out of the lead lumen.The physician used a hemostat clamp to grasp the guidewire, but even with considerable force he was not able to remove it.The lead was then removed from the body.It was noted that the guidewire was in the body approximately 10 minutes prior to the physician's attempt to withdraw it, and that it had been flushed on the table during surgical preparation.The lead was not used and another lead was implanted.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Evaluation summary: the full lead was returned in segments and analyzed.The analysis indicated that the distal conductor of the lead became extrinsically distorted due to pulling/stretching/overstress.The low voltage 4 conductor was extrinsically pulled/stretched.The low voltage 3 conductor was distorted due to pulling/stretching.The proximal conductor of the lead became extrinsically distorted due to pulling /stretching/overstress.Visual analysis of the lead indicated damage at implant.The analyst noted that the full lead was returned in segments.The guidewire was not returned with the lead.There are distorted conductors located throughout the lead.If information is provided in the future, a supplemental report will be issued.

• 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: 8250380
• MDR Text Key: 133204549
• Report Number: 2649622-2019-00858
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601871
• UDI-Public: 00643169601871
• 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: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2020
• Device Model Number: 459888
• Device Catalogue Number: 459888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2018
• 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: 81 YR
• Patient Weight: 63