MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0302

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report the displacement of the pacing lead.It was reported that this was a mitraclip procedure to treat grade 3-4 degenerative mitral regurgitation (mr).One mitraclip was successfully implanted reducing mr to grade 1-2.When the steerable guide catheter (sgc) was retracted into the right atrium according to the instructions for use, the sgc interacted with the right ventricular pacing lead and dislodged the lead.A temporary pacing lead was inserted before a new right ventricular pacing lead was implanted.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Review of the complaint history identified no similar incidents reported from this lot.The reported device causing damage to another device (pacer lead) appears to be a combination of the patient morpholgy/pathology and user technique/procedural conditions.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7820591
• MDR Text Key: 118389121
• Report Number: 2024168-2018-06634
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80402U114
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 85