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

Catalog Number SGC0302

Device Problem Difficult to Insert (1316)

Patient Problems Fistula (1862); Hematoma (1884); Tissue Damage (2104)

Event Date 02/14/2019

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 is filed for femoral arteriovenous fistula and hematoma.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was inserted with resistance noted.Two clips were implanted, reducing the mr to 2.Access site hemostasis was achieved with sutures and manual compression.The day following the procedure, a hematoma was noted on the patient's thigh.Five days post procedure, when the sutures were removed, the hematoma worsened.A ct scan confirmed a femoral fistula and the patient was sent to surgery for arteriovenous repair the following day.Peeling of the inner member of the artery was observed.Blood transfusion was performed.No additional information was provided.

Manufacturer Narrative

Patient codes: 2104 labeled.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.The reported adverse event of hematoma, arteriovenous fistula and vascular trauma as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.All available information was investigated and a definitive cause for the reported difficult to insert the sgc into the patient anatomy could not be determined in this incident.The reported hematoma appears to be due to patient/procedural circumstances.However, a definitive cause for the reported fistula and tissue damage could not be determined in this case.There is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.

• 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: 8414631
• MDR Text Key: 138632820
• Report Number: 2024168-2019-01962
• 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: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80921U145
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM (X2)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 88 YR