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

Model Number SGC0701

Device Problems Leak/Splash (1354); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This is filed to report a leak requiring intervention.It was reported that the patient underwent a mitraclip procedure to treat functional mitral regurgitaion (mr) with a grade of 4.While introducing the clip delivery system (cds) into the steerable guide catheter (sgc) there was loss of fluid column.There was air in the device and aspiration was performed to remove the air.The physician tried several times but it kept loosing fluid.The sgc was replaced with a new one and the procedure continued.One clip was implanted and the mr was reduced to a grade of <1.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

Subsequent to the initial report, the additional information was received that this was a duplicate of a previously reported event, (b)(4).The event and investigation will be captured in (b)(4).(b)(4) initial medwatch report number -- 2135147-2022-01624-00.(b)(4) supplemental medwatch report number -- 2135147-2022-01624-01.(b)(4) final report number, capturing the event, and device return analysis -- 2135147-2022-01624-02.D9: device return date added.The device return analysis, and investigation will be reported in a duplicate cn, (b)(4).E: primary operator name updated.H3: device return updated to yes.The device return analysis and investigation will be reported in a duplicate cn, (b)(4).H6: health effect ¿ impact code 4641 removed and replaced with 2199 as this cn was discovered a duplicate and (b)(4) will capture the event.Medical device problem code 1354 removed and replaced with 3189 as this cn was discovered a duplicate and (b)(4) will capture the event.

Event Description

Subsequent to the initial report, the additional information was received that this was a duplicate of a previously reported event, (b)(4).The event and investigation will be captured in (b)(4).(b)(4) initial medwatch report number -- 2135147-2022-01624-00.(b)(4) supplemental medwatch report number -- 2135147-2022-01624-01.(b)(4) final report number, capturing the event, and device return analysis -- 2135147-2022-01624-02.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• 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: 15611260
• MDR Text Key: 301820163
• Report Number: 2135147-2022-01633
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2023
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 20329R325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2022
• 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
• Treatment: CLIP DELIVERY SYSTEM.
• Patient Outcome(s): Required Intervention