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

Catalog Number SGC0301

Device Problems Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was discarded.Investigation is not yet complete.A follow up report will be submitted with additional information.

Event Description

This report is filed due to unintended movement of the steerable guide catheter knob.It was reported that this was a mitraclip procedure treating degenerative mitral regurgitation (dmr) grade 4.Following device preparation per ifu and without issues, the steerable guide catheter (sgc) plus (+) knob was turned approximately 180 degrees, however, the knob would spin back and would not hold in place.In order to maintain the + knob position, with the expected sgc deflection, once the + knob was turned into place, the + knob had to be held in that place and the device operated as expected with no other issues.The sgc would deflect as expected if the knob was held in place.This same device was used in the procedure.Two clips were implanted, reducing the mr to grade 1.There were no adverse patient effects and there was no clinically significant delay.No additional information was provided regarding this issue.

Manufacturer Narrative

Internal file number - (b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Per eifu, mitraclip nt clip delivery system: remove hand from the plus/minus knob and check that the knob does not slip and, do not use device if damage is detected.Use of damaged product may result in air embolism, vascular and/or cardiac injury.All available information was investigated, and the reported knob slippage appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• 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: 8735953
• MDR Text Key: 149236459
• Report Number: 2024168-2019-05121
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2019
• Device Catalogue Number: SGC0301
• Device Lot Number: 81030U118
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TWO MITRACLIPS; TWO MITRACLIPS
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR