MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER; CATHETER, STEERABLE

Model Number SGC0301

Device Problems Fluid/Blood Leak (1250); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2020

Event Type  malfunction  

Event Description

Hemostatic valve failure on steerable guide, i.E., leaking, and a new device was opened and used.Procedural note: "the right groin region was anesthetized with 20ml of xylocaine.The common femoral vein was accessed and two proglide devices were deployed.The patient was fully anticoagulated.We took an sl0 transseptal sheath and a bk needle and a transseptal puncture was performed about 4 cm from the mitral annulus.We then positioned the amplatz wire in the left upper pulmonary vein.We used dilators and then advanced a 24-french guide sheath.Upon removing the wire and the dilator, the ____ was lost within the guide sheath.We tried to reposition the guide sheath within the left atrium in case we were against the wall, but it kept losing the ____.This was suggested that there is something faulty with the device, although it appeared to be okay pre-introduction into the body.We therefore advanced a safari small curve into the left atrium, removed the guide sheath, and introduced a new guide sheath.We then proceeded to position a mitraclip ntr grasping the anterior and posterior mitral leaflets just lateral to a2 and p2.Our mean gradient average was 3 mmhg.The worst degree of mitral regurgitation was 1+.This was a medial jet that we were not going to pursue due to the baseline mean gradient of 3 mmhg.There was good tissue bridge.The device was released.No changes were noted after the device was released.The guide sheath was removed and two proglide devices were deployed with good hemostasis.The patient was sent to recovery room in stable condition.".

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 3200 lakeside dr; santa clara CA 95054
• MDR Report Key: 10118386
• MDR Text Key: 194001517
• Report Number: 10118386
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 00214U117
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Weight: 94