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

Model Number 429888

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 12/12/2018

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 implant attempt, a competitor interventional wire could not be removed from the lead, with attempts to retract it resulting in the lead pulling back into the body.The lead was not used and another lead was implanted.The patient was noted to be enrolled in the product surveillance registry.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Evaluation summary: the full lead was returned and analyzed.Analysis indicated that the distal conductor of the lead was obstructed due to a stylet/guidewire stuck in the lumen.The stylet/guidewire was kinked/buckled.The distal conductor was extrinsically distorted due to kinking/buckling.The distal conductor of the lead became extrinsically distorted due to stylet/guidewire coating.There was blood on the distal conductor of the lead and it was not obstructed.The tip seal on the distal electrode of the lead showed evidence of blood ingress.Visual analysis of the lead indicated damage at implant.The analyst noted that the lead was returned with the competitor guidewire still inserted in lead.It was easy to remove the guidewire from lead.Visual inspection was performed on the lead and the guidewire.Analysis results lead us to conclude that the competitor guidewire's hydrophilic coating adhered to the coil filars causing the guidewire to stick in the lead lumen.As a result, the coil filars became distorted when trying to pull the guidewire out of the lead during implant attempt.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: 8225841
• MDR Text Key: 132343914
• Report Number: 2649622-2019-00341
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601833
• UDI-Public: 00643169601833
• 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: 01/23/2019

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: Health Professional
• Device Expiration Date: 07/30/2020
• Device Model Number: 429888
• Device Catalogue Number: 429888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 01/23/2019
• Supplement Dates FDA Received: 01/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2018
• 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
• Treatment: UNK COMPETITOR WHISPER WIRE
• Patient Age: 65 YR
• Patient Weight: 94