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

Model Number SGC0701

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Pericardial Effusion (3271)

Event Date 05/20/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for evaluation. It has not yet been received. A follow-up report will be submitted with all additional relevant information. The additional device filed under a separate medwatch report number. Na.

Event Description

This is filed to report leak, air embolism, cardiac arrest, pericardial effusion, pericardiocentesis, cpr and hospitalization. It was reported that this was a mitraclip procedure to treat severe degenerative mitral regurgitation (dmr). During use of the steerable guide catheter (sgc) (10204u442), the device would not hold fluid column. After drawing back on the syringe the device would lose the fluid column. Some air bubbles were seen in the anatomy and aspiration was required. The sgc was removed and replaced and again with the new sgc (lot 10217u232), fluid column was lost and aspiration was required although there were no bubbles seen in the anatomy with this device. The second sgc was removed and replaced and there were no issues with the third sgc and mr was reduced to mild. The starting mean pressure gradient (mpg) was 1 mmhg and the ending mpg was 3 mmhg. There were no adverse patient effects during the procedure; however, post procedure the patient coded and was stabilized quickly after cardiopulmonary resuscitation (cpr). There was pericardial effusion which was treated with pericardiocentesis. It is thought that a wire somewhere caused the effusion during the exchange of devices. The patient was hospitalized one additional day. 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: 11979584
• MDR Text Key: 263496913
• Report Number: 2024168-2021-04906
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/04/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10204U442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2021
• 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: 06/10/2021 Patient Sequence Number: 1