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

Model Number SGC0701

Device Problems Leak/Splash (1354); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation has not been completed.A follow up report will be submitted with all additional relevant information.

Event Description

This is being filed to report the steerable guide catheter (sgc) leak.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with grade 4.The steerable guide catheter (sgc) was advanced but could not cross the septum as that area was thicker.Therefore, it was decided to make a new hole.The sgc was removed and during re-flushing of the sgc, it was observed that the hemostatic valve didn¿t hold the water column.The sgc was exchanged with a new sgc.The new sgc was advanced through a new hole without issued.One clip was implanted, 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

All available information was investigated and the reported leak (loss of fluid column) could not be confirmed/tested via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar complaints.Based on the information reviewed the loss of fluid column was due to the silicone valve tear.A cause for the silicone valve tear could not be determined.The reported failure to advance appears to be due to patient conditions.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: 10712781
• MDR Text Key: 212360611
• Report Number: 2024168-2020-08796
• 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: 12/18/2020

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: 06/25/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00623U530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 98