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

Catalog Number SGC0302

Device Problems Difficult to Insert (1316); Deformation Due to Compressive Stress (2889)

Patient Problem Air Embolism (1697)

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 report is filed as air was observed in the anatomy.It was reported that the patient presented with functional mitral regurgitation grade 4.Following transseptal puncture, the steerable guide catheter (sgc) was difficult to insert into the femoral vein due to anatomy.Insertion was attempted a few times with eventual success.One mitraclip was implanted without reported issues, reducing the mr to <1.Once the sgc was removed from the patient's anatomy, a dent was noted at the sgc tip curve.Reportedly, there were no tears noted at the soft tip.In addition, per echocardiogram, air was observed in the pulmonary vein.No treatment was provided.There was no adverse patient sequela.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.It should be noted that the reported patient effect of air embolism, as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures.All available information was investigated and the reported difficult to insert the steerable guide catheter (sgc) in this incident appears to be related to patient challenging anatomy.The reported material deformation (dent on the sgc tip) appears to be cascading effect of difficulty to insert.Lastly, the cause of reported patient effect of air embolism could not be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.

Manufacturer Narrative

Internal file number - (b)(4).Correction: patient weight updated from 41kg to 40kg (40.4kg).

Event Description

Subsequent to the previous medwatch report, the additional information was received: the steerable guide catheter (sgc) shaft had a dent at the initial shaft curve.

• 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: 8301780
• MDR Text Key: 134890870
• Report Number: 2024168-2019-00800
• 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,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80919U236
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 02/04/2019
• Supplement Dates Manufacturer Received: 03/22/2019; 04/25/2019
• Supplement Dates FDA Received: 04/04/2019; 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MITRACLIP CLIP DELIVERY SYSTEM; MITRACLIP CLIP DELIVERY SYSTEM
• Patient Outcome(s): Other
• Patient Age: 89 YR
• Patient Weight: 40