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

Catalog Number SGC0302

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001.The customer reported the device is not returning.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 perforation, dissection, hemorrage, and medical intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was inserted into the femoral vein.However, prior to crossing the septum, resistance was felt when raising the sgc to the inferior vena cava.It was noted that the sgc was difficult to advance due to a loose guide wire that had a loop.Angiography confirmed that the iliac vein was bleeding which resulted in a clinically significant delay in the procedure.The hemorrage was due to either a dissection or a perforation.It is unknown if the sgc or the guide wire caused the bleeding.The procedure was aborted to reverse the heparin and perform balloon hemostasis.The patient returned to intensive care unit with intubation for overnight follow-up.The patient stable.No clips were implanted, and mr is 4.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 revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The investigation determined the reported difficult to advance appears to be related to user technique/procedural conditions.The hemorrhage appears to be due to the perforation.The perforation was likely caused by the steerable guide catheter or guide wire; therefore, attributed to procedural conditions.The reported patient effects of hemorrhage and perforation, 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: 9273194
• MDR Text Key: 164882261
• Report Number: 2024168-2019-13161
• Device Sequence Number: 1
• Product Code: DRA
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90627U129
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 51