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

Model Number SGC0701

Device Problems Difficult to Remove (1528); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/18/2021

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 additional device referenced is filed under a separate medwatch report number.

Event Description

This is filed to report difficult to remove and unintended movement it was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.It was noted tha the patient was decompensated and was not a surgical candidate.An impella device was implanted prior to the mitraclip procedure.Then a steerable guide catheter (sgc) was advanced to the mitral valve.The first clip delivery system (xtw cds) was advanced through the sgc and the clip was placed without issue.But mr did not reduce.Therefore, the xtw cds was to be removed.However, the user inadvertently pulled back the sgc hard and the sgc jumped across the septum.Then as the cds was being pulled back, the clip became stuck in the hemostatic valve.The cds was able to be removed from the sgc with the clip attached.The sgc was used to re-wire and gain transseptal access.The procedure continued with an ntw clip.Two clips were implanted, reducing mr to 2.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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 did not indicate a lot-specific product issue.All available information was investigated and the reported unintended movement associated with the steerable guide catheter (sgc) jumping across the septum and difficult clip delivery system removal from the sgc appear to be related to user technique/procedural circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

Event Description

N/a.

• 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: 12128450
• MDR Text Key: 260274984
• Report Number: 2024168-2021-05767
• 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: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 01026U120
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/07/2021
• Supplement Dates Manufacturer Received: 08/26/2021
• Supplement Dates FDA Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; IMPELLA DEVICE; CLIP DELIVERY SYSTEM; IMPELLA DEVICE
• Patient Age: 65 YR
• Patient Weight: 78