MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE

Model Number SGC0701

Device Problems Product Quality Problem (1506); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The mitraclip system and implanted clip referenced are filed under a separate medwatch report numbers.

Event Description

This is filed to report damaged steerable guide catheter hemostasis valve (00225u828).It was reported this was a mitraclip procedure performed to treat grade 4 mixed mitral regurgitation (mr).The steerable guide catheter (00225u828) was inserted and the mitraclip delivery system (cds) (00310u167) was advanced to the mitral valve.The leaflets were grasped without issue; however, the clip repeatedly failed to establish final arm angle (efaa), and troubleshooting was unsuccessful.The clip was not implanted.When removing the cds, the fully closed clip got caught on the clip introducer and the tip of the clip introducer became mangled, causing damage to the sgc hemostasis valve.The clip was fully closed but could not be removed from the sgc hemostasis valve.The devices were removed together.A new sgc and cds (00310u166) were advanced.Grasping was successful and the clip was implanted without issues, reducing mr to 2.It is suspected the implanted clip (00310u166) caused an anterior leaflet tear.In an attempt to further reduce mr, another clip was advanced and grasping was successful.However, mr would not reduce any further; therefore, the clip was not implanted and was removed.No attempt was made to treat the anterior leaflet tear.A total of one clip was implanted, mr was reduced to 2.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to these events.Additionally, a review of the complaint history identified no other incidents for the reported lot.Based on the information reviewed, the reported product quality problem (unknown damage on hemostasis valve) appears to be due to clip caught clip introducer (difficult to remove cds/sgc).However, a cause for how the clip got caught on the clip introducer (difficult to remove) cannot be determined.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10434320
• MDR Text Key: 204049296
• Report Number: 2024168-2020-06974
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00225UA28
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MITRACLIP DELIVERY SYSTEM
• Patient Age: 68 YR