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

Catalog Number SGC0705

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

Patient Problem Perforation (2001)

Event Date 07/26/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation; the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The first clip implanted referenced is filed under a separate medwatch report number - 2024168-2021-06810-00.

Event Description

This is being filed to report that after removal of the steerable guide catheter (sgc), a left to right shunt was observed.It was reported that the initial mitraclip procedure was performed on (b)(6)2021 to treat functional mitral regurgitation (mr) with grade 4.One clip was implanted, reducing mr to 2.On (b)(6) 2021, during postoperative transthoracic echocardiography (tte), the patient had recurrent mr with grade of 3-4.The clip was confirmed to be stable on the leaflets and there was no evidence of tissue damage.The patient remained hospitalized.On (b)(6) 2021, an additional clip was implanted, reducing mr from 3-4 to 1.After the steerable guide catheter (sgc) was removed, a left to right shunt occurred and was treated with a closure device was placed to treat 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 this event.Based on available information, a cause for the reported atrial perforation could not be determined.Additionally, atrial perforation is listed in the instruction for use (ifu) as a known possible complication associated with mitraclip procedures.The reported use of an atrial septal defect (asd) closure device was the 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: 12315366
• MDR Text Key: 266302580
• Report Number: 2024168-2021-07121
• Device Sequence Number: 1
• Product Code: DRA
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2022
• Device Catalogue Number: SGC0705
• Device Lot Number: 10210U156
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 IMPLANTED MITRACLIP; 2 IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 56