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

Catalog Number SGC0301

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Test Result (2695)

Event Date 12/04/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001.The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is being filed to report a perforation, hypotension, medical intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.It was noted difficulty placing an intra-cardiac echocardiography (ice) catheter.After the transseptal puncture was performed, a steerable guide catheter (sgc) was advanced to the mitral valve.However, the patient became unstable as the patient¿s blood pressure dropped and there was a drop-in hematocrit.The patient was stabilized, and fluoroscopy showed a puncture in the inferior vena cava, above the iliac vein bifurcation.The physician feels the puncture occurred during placement of the ice catheter, but this cannot be confirmed.A decision was made to remove the sgc and abort the procedure.The puncture was treated with a intravascular balloon, and the bleeding was controlled.The patient required one unit of blood and an iv fluid.The patient was transferred to the intensive care unit and the patient is stable.No clips were implanted, and mr is 4.There was 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 not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.In this case, there was no reported device malfunction associated with the steerable guide catheter (sgc).The investigation determined the reported perforation, test result, hemorrhage and hypotension appear to be related to procedural conditions.The reported patient effects of perforation, test result, hemorrhage and hypotension as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 9489572
• MDR Text Key: 175389506
• Report Number: 2024168-2019-14688
• 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: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90716U132
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 66