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

Catalog Number SGC0705

Device Problems Leak/Splash (1354); Failure to Advance (2524)

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

Event Date 05/11/2022

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

This is being filed to report the leak.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with a grade of x.The steerable guide catheter (sgc) was advanced into the patient anatomy however only the dilator was able to advance into the septum as the sgc could not.The sgc was removed and the septum was dilated with a balloon.While preparing the sgc for the second attempt there was a loss of fluid column noted in the hemostatic valve.The sgc was tested twice and still failed therefore a new sgc was used.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Event Description

Subsequent to the initially filed report, the following information was received: pre procedure mr was a grade of 4, post procedure mr was a grade of 1, and two clips were implanted.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported loss of fluid column could not be confirmed via returned device analysis.The reported failure to advance could not be replicated in a testing environment.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 incidents reported from this lot.Based on available information and the results of the analysis, a cause of the reported loss of fluid column could not be determined.The reported failure to advance appears to be due to procedural circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 14574953
• MDR Text Key: 293278834
• Report Number: 2024168-2022-05892
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2022
• Device Catalogue Number: SGC0705
• Device Lot Number: 11209R156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2021
• 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 Sex: Male
• Patient Weight: 70 KG