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

Catalog Number SGC0705

Device Problems Difficult or Delayed Positioning (1157); Difficult to Advance (2920)

Patient Problems Hemorrhage/Bleeding (1888); Respiratory Failure (2484); Unspecified Tissue Injury (4559)

Event Date 05/31/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This is filed to report hemorrhage, intervention, delay, tissue injury. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mmr) with a grade of 4. The steerable guide catheter (sgc) was difficult to advance through the non-abbott sheath after puncturing the atrial septum and it was expanded with a 5x20 mm balloon dilatation catheter. The sgc was then able to pass through although there was resistance. Next, the clip delivery system (cds) was advanced to the mitral valve and noted small prolapse on the a2 medial site. The clip was placed in the center of a2p2 and mild mr could be seen on the medial side of a2p2 but mr decreased significantly to grade of 1. No device issues were noted with the cds and there were no adverse patient effects due to the cds. When the patient was waking from anesthesia, there was bleeding noted from the bronchi. It is suspected that the likely cause was damage to the pulmonary veins caused by the guide wire during insertion of the sgc. The heparin was neutralized with protamine and the patient returned to the room with intubation. Positive pressure ventilation is being used to promote hemostasis. The patient was extubated the next day and there was no prolonged hospitalization. There was a clinically significant delay in the procedure. No additional information was provided.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12033618
• MDR Text Key: 257209641
• Report Number: 2024168-2021-05204
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/11/2022
• Device Catalogue Number: SGC0705
• Device Lot Number: 10112U133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/21/2021 Patient Sequence Number: 1

Treatment

CDS LOT 10128U160; SWARTZ SHEATH