MAUDE Adverse Event Report: ABBOTT MEDICAL STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number UNK SGC

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

Patient Problems Hypoxia (1918); Perforation (2001)

Event Date 10/18/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.The lot history record review was not performed because this complaint is based on an article review, and no part or lot information was provided.Based on available information, a cause for the reported atrial perforation could not be determined.The reported hypoxia appears to be a cascading event of the atrial perforation.The reported patient effect of atrial perforation is listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.The reported unexpected medical intervention and hospitalization were the results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.Implant/explant,event and outcomes attributed to adverse event dates estimated.The udi number is not known as the part and lot number were not provided.

Event Description

This is filed to report an atrial septal defect (asd) and hypoxia requiring intervention.It was reported in an article that the patient underwent a mitraclip procedure to treat severe functional mitral regurgitation (mr) and a left atrial appendage closure procedure using a non-abbott device.An xtw mitraclip was successfully implanted on the lateral side of a2-p2 and the procedure was concluded successfully.One day later, a bidirectional iatrogenic asd was recognized due to the patient desaturating during rehabilitation.Four days after the mitraclip procedure, an additional procedure was performed to treat the asd using an amplatzer occluder without reported complication.There was no clinically significant delay in the procedure and no adverse patient sequelae.No additional information was provided.Details are listed in the article titled, "simultaneous procedure of watchman and amplatzer implantation after mitraclip".

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16500048
• MDR Text Key: 310853484
• Report Number: 2135147-2023-01048
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SGC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Male