MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number SGC0301

Device Problems Leak/Splash (1354); Unstable (1667)

Patient Problem No Patient Involvement (2645)

Event Date 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4).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.The clip delivery system referenced is being filed under a separate medwatch report.

Event Description

This is being filed to report during preparation of the steerable guide catheter, the rhv of the dilator was leaking.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with grade of 4+.During preparation of the steerable guide catheter, the rotating hemostatic valve (rhv) of the dilator was loose when turning and could not be tightened.Saline was noted to be leaking from the rhv; therefore, the sgc was not used in the patient.A new sgc with dilator were used in the procedure.The clip delivery system (cds) was advanced to the mitral valve and the clip was placed.The gripper line was fully mobile, and flossing was performed with not issues or tension.The clip was deployed successfully, reducing mr to 2+.During gripper line removal, the gripper line was pulled about 12-24 cm, and the small end of the gripper line became stuck.It was decided to remove the cds over the gripper line which exposed both gripper lines and both were pulled one at a time but both ends were now stuck.The physician continued with troubleshooting but was unsuccessful and it was decided to cut the gripper lines at the groin and leave inside the patient.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The reported issue of unstable valve resulting in leak appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9083540
• MDR Text Key: 169531710
• Report Number: 2024168-2019-11882
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90601U212
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 11/27/2019
• Supplement Dates FDA Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 81