MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER; VALVE REPAIR

Model Number SGC0301

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2020

Event Type  malfunction  

Manufacturer Narrative

It is unknown at this time if the steerable guide catheter is returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

User facility medwatch report received that states, "hemostatic valve failure on steerable guied, i.E., leaking, and a new device was opened and used.Procedural note: " the right groin region was anesthetized with 20 ml of xylocaine.The common femoral vein was accessed and two proglide devices were deployed.The patient was fully anticoagulated.We took an slo transeseptal sheath and a bk needle and a transseptal puncture was performed about 4 cm from the mitral annulus.We then positioned the amplatz wire in the left upper pulmonary vein.We used dilators and then advanced a 24-french guide sheath.Upon removing the wire and the dilator, the____ was lost within the guide sheath.We tried to reposition the guide sheath within the left atrium in case we were against the wall, but it kept losing the _____.This was suggested that there is something faulty with the device, although it appeared to be okay pre-introduction into the body.We therefore advanced a safari small curve into the left athrium, removed the guide sheath, and introduced a new guide sheath.We then proceeded to position a mitraclip ntr grasping the anterior and posterior mitral leaflets just lateral to a2 p2.Our mean gradient average was 3 mmhg.The worst degree of mitral regurgitation was 1+.This was a medial jet that we were not going to pursue due to the baseline mean gradient of 3 mmhg.There was good tissue bridge.The device was released.No changes were noted after the device was released.The guide sheath was removed and two proglide devices were deployed with good hemostatis.The patient was sent to recovery room in stable condition." what was the original intended procedure?: transseptal puncture and placement of mitraclip ntr times 1." no additional information was provided.Additional customer follow-up information was received: this was a mitraclip procedure to treat mitral regurgitation (mr) with a grade of 3-4.The steerable guide catheter was advanced; however a leak on the hemostatic valve was observed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and a definitive cause for the reported leak could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10398463
• MDR Text Key: 202801476
• Report Number: 2024168-2020-06723
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2021
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 00214U117
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TWO PROGLIDE CLOSURE DEVICES
• Patient Age: 75 YR
• Patient Weight: 94