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

Catalog Number SGC0301

Device Problems Crack (1135); Leak/Splash (1354); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

This is being filed to report leak and medical intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) grade of 4.A steerable guide catheter (sgc) was advanced to the mitral valve; however, as the clip introducer was inserting into the sgc, air was observed in the chamber of the sgc.The clip introducer was immediately removed and aspirations was performed to ensure air did not enter the patient.The sgc was then removed from the patient to be re-prepped.During the second preparation, the fluid column was closely observed to ensure fluid would hold.But when the hemostatic valve was tapped, the flush port became separated from the sgc.It was suspected that the flush port must have had a crack.The sgc was not used and the procedure was successfully completed with another sgc.One clip was implanted, reducing mr to 1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

G9: 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 returned.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.In conclusion, the reported issue of the cracked/broken flush port was confirmed via returned device analysis.The reported leak could not be replicated in a testing environment as the flush port was returned broken.The flush port was submitted for scanning electron microscope (sem) analysis to investigate the failure mode of the cracked/broken flush port.From the evidence found during this analysis, it appeared that the flush port broke by coalescencing of crazes and brittle fracture paths yielding a brittle type fracture.The investigation determined that the reported issue of the cracked/broken flush port resulting in the reported leak appears to be related to a potential product 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: 9371360
• MDR Text Key: 167992482
• Report Number: 2024168-2019-13887
• 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: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90809U107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR
• Patient Weight: 62