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

Catalog Number SGC0301

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.The additional clip delivery systems referenced are filed under a separate medwatch report.

Event Description

This is being filed to report the torn tip of the sgc.It was reported that this was a mitraclip procedure performed to treat mixed mitral regurgitation (mr) with an mr grade of 4.Imaging was difficult due to the rotated heart.The steerable guide catheter (sgc) and the clip delivery system (cds 70713u170) were advanced to the mitral valve.When applying m knob, the cds moved in the p direction.When applied again, the cds had normal movement.It was noted that the puncture height was too low and the decision was made to remove the system and perform a higher puncture.During removal of the cds, the clip was caught in the chordae and also became caught on the tip of the sgc.Troubleshooting was performed and the clip was freed; however, a chordae rupture occurred and the mr increased from to 4+.The clip was able to be retracted into the sgc without further issue, but after removal, chordae tissue was noted on the clip and the sgc tip was torn.A second transseptal puncture was performed, and a new sgc and new cds (70713u169) were advanced.The clip was implanted successfully in a2p2; however, a second jet was created due to chordal rupture.Another clip (70713u173) was advanced, but due the position of the jet, there was difficulty positioning the clip making grasping impossible.The clip then got caught in a previously implanted mitral valve ring.The clip was freed and then deployed successfully.Two clips were implanted, reducing the mr to 3-4.The procedure was extended 2 hours due the chordae rupture and second transseptal puncture.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: all available information was investigated and the reported steerable guide catheter (sgc) torn soft tip was confirmed.The reported poor image resolution could not be replicated in a testing environment as it was related to patient/procedural conditions (operational circumstances).A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history identified no other incidents reported from this lot.All available information was investigated and the reported torn soft tip was a result of the clip getting caught on the guide tip; therefore, attributed to procedural conditions.The reported poor image resolution appears to be related to patient anatomy due to the rotated heart.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, 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: 7271472
• MDR Text Key: 100277914
• Report Number: 2024168-2018-01109
• 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: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2018
• Device Catalogue Number: SGC0301
• Device Lot Number: 70626U129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Date Manufacturer Received: 03/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM
• Patient Age: 58 YR