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

Model Number SGC0701

Device Problem Unintended Movement (3026)

Patient Problem Thrombosis (2100)

Event Date 09/14/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This is filed to report thrombus.It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation with an mr grade of 4+.The steerable guide catheter was advanced, and two clips were implanted without issue.However, when retracting the mitraclip delivery system after the second clip was implanted, the sgc inadvertently slipped from the left atrium (la) into the right atrium (ra).Thrombus was noted in the ra and in the la.Heparin was given and aspiration was performed with no luck.Mr was reduced to 4.The patient is doing good.Thrombus was monitored for stability throughout the end of the case.There was no additional information 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 issue.A review of the compliant history identified no similar incident reported from this lot.The reported patient effect of thrombosis is listed in the instructions for use as a known possible complication associated with mitraclip procedures.Based on information reviewed, a definitive cause for the reported unintended movement and patient effect of thrombosis could not be determined.The reported additional therapy/non-surgical treatment and treatment with medication were a result of case specific circumstances.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: 10639718
• MDR Text Key: 214617094
• Report Number: 2024168-2020-08319
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00316U146
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP(X2)
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 45