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

Catalog Number SGC0702

Device Problem Device Damaged by Another Device (2915)

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

Event Date 04/06/2023

Event Type  malfunction  

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 incidents reported from this lot.Based on available information, the reported device damaged by another device (caused damage) associated with the sgc interacting with the pacemaker leads was due to procedural circumstances (proximity of pacemaker leads to path of travel for the sgc) during sgc removal.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Na.

Event Description

This is filed to report device damaged another device.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 3, slightly degenerated anterior mitral leaflet (aml) and posterior mitral leaflet (pml), pml was only 7.5mm long, and posterior aspect of the annulus and parts of the pml were calcified.A mitraclip ntw was implanted, but following implant, a single leaflet device attachment (slda) occurred.The clip had detached from the posterior leaflet and remained attached to the anterior leaflet.To stabilize the slda clip, a second clip was implanted.The physician¿s assessment for the cause of the slda was due to shortness of the pml, and not having enough posterior leaflet inserted.The procedure was completed with two clips implanted.The mr was reduced to grade 1-2.There was no clinically significant delay in the procedure and no adverse patient effects.One day after the procedure, due to not using fluoroscopy while removing the steerable guide catheter, the pacemaker leads in the right atrium and ventricle (ra and rv) were observed to have detached.A pacemaker change will be required.No additional information provided.

• 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: 16843626
• MDR Text Key: 314288526
• Report Number: 2135147-2023-01886
• 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: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2024
• Device Catalogue Number: SGC0702
• Device Lot Number: 30106R1091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2023
• 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