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

Model Number SGC0701

Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

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

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report soft tip damage.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with grade 4.The steerable guide catheter (sgc) was inserted into the groin without issue, but resistance was felt and was unable to advance through the septum.It was decided to remove the sgc and use a new dilator.The first and second dilator were advanced without issue.The sgc was reinserted and advanced up to the septum but could not cross the septum.Therefore, the sgc was removed from the patient anatomy.Outside the patient anatomy it was noted that the soft tip was damaged, the soft tip appeared to have a peak (stretched) but no tear was visible.A new sgc was advanced without issue.During preparation of the clip delivery system (cds), the clip established final arm angle (efaa) successfully, but the clip would not open after.Multiple attempts were made but the clip remained closed.There was no patient involvement with this cds.Two clips were implanted successfully, reducing mr to 1.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The returned device analysis confirmed the reported deformation due to compressive stress.The reported failure to advance could not be replicated in a testing environment as it was related to procedural/operational circumstances.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 a cause for the reported failure to advance the steerable guide catheter (sgc) resulting in the deformed (stretched) soft tip cannot be determined.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

• 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: 11605413
• MDR Text Key: 250395549
• Report Number: 2024168-2021-02641
• 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: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 01222U254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 85