MAUDE Adverse Event Report: ABBOTT MEDICAL G4 STEERABLE GUIDING CATHETER (CE); CATHETER, STEERABLE

Catalog Number SGC0702

Device Problem Failure to Advance (2524)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 06/21/2023

Event Type  Injury  

Event Description

This is filed to report a pericardial effusion.It was reported that a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) grade 3-4.The patient had an existing pericardial effusion.The transseptal puncture was difficult and the steerable guide catheter (sgc) was unable to cross the septum.The patient then had to be resuscitated.Following, resuscitation, the transseptal puncture was performed again but unfortunately the patient¿s blood pressure dropped and cpr was performed.Difficulties visualizing the wire in the left atrium (la) occurred.Pericardiocentesis was performed to treat the existing pericardial effusion.The sgc worsened the existing pericardial effusion.The procedure was aborted with no clips implanted.The mr remained at grade 3-4.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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the cause of the reported failure to advance and difficult imaging were unable to be determined.The reported pericardial effusion was due to a combination of patient condition and procedural circumstances.The reported hypotension and cardiac arrest were cascading events of the pre-existing pericardial effusion.The reported patient effects of hypotension, cardiac arrest, and pericardial effusion, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER (CE)
• Type of Device: CATHETER, STEERABLE
• 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: 17354436
• MDR Text Key: 319347915
• Report Number: 2135147-2023-03100
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Catalogue Number: SGC0702
• Device Lot Number: 30301R2095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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