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

Model Number SGC0701

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 02/09/2021

Event Type  Injury  

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 tissue damage.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was prepped per the instructions for use and was inserted without issues.However, when the sgc crossed the septum, an object was noticed on the tip of the sgc; therefore, aspiration was performed.The object was unable to be removed, so the physician decided to remove the entire device.Once outside the anatomy, it was noticed that 1-2cm of tissue was stuck to the tip of the sgc.The physician felt as though the tissue damage was caused during advancement of the sgc.Once the tissue was removed, the sgc was reinserted.An ntw clip was then implanted without issues.To further reduce mr, a second clip was inserted and deployed laterally of the ntw clip.However, after the clip was deployed, the ntw clip detached from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda).The clip was stable on the posterior leaflet and mr was reduced to a grade of 2, so the physician decided to not implant an additional clip and discontinue the procedure.There was no 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 revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on available information, the reported unspecified tissue injury appears to be due to procedural conditions.Additionally, the reported patient effect of unspecified tissue injury is listed in the instructions for use as a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention (pti) is the result of case-specific circumstances, as aspiration was performed due to the reported issues.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: 11405602
• MDR Text Key: 234483982
• Report Number: 2024168-2021-01679
• 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: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 01120U311
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 03/04/2021
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 70