MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE

Catalog Number SGC0705

Device Problems Difficult or Delayed Positioning (1157); Difficult to Advance (2920)

Patient Problems Hemorrhage/Bleeding (1888); Respiratory Failure (2484); Unspecified Tissue Injury (4559)

Event Date 05/31/2021

Event Type  Injury  

Manufacturer Narrative

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 filed to report hemorrhage, intervention, delay, tissue injury.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mmr) with a grade of 4.The steerable guide catheter (sgc) was difficult to advance through the non-abbott sheath after puncturing the atrial septum and it was expanded with a 5x20 mm balloon dilatation catheter.The sgc was then able to pass through although there was resistance.Next, the clip delivery system (cds) was advanced to the mitral valve and noted small prolapse on the a2 medial site.The clip was placed in the center of a2p2 and mild mr could be seen on the medial side of a2p2 but mr decreased significantly to grade of 1.No device issues were noted with the cds and there were no adverse patient effects due to the cds.When the patient was waking from anesthesia, there was bleeding noted from the bronchi.It is suspected that the likely cause was damage to the pulmonary veins caused by the guide wire during insertion of the sgc.The heparin was neutralized with protamine and the patient returned to the room with intubation.Positive pressure ventilation is being used to promote hemostasis.The patient was extubated the next day and there was no prolonged hospitalization.There was a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.The investigation determined the reported difficult or delayed positioning in the anatomy was due to the difficult to advance the device.However, a cause for the difficult to advance cannot be determined.The reported tissue injury appears to be related to procedural condition.The hemorrhage and subsequent respiratory failure were cascading effects of the tissue injury.The reported patient effects of unspecified tissue injury, hemorrhage and respiratory failure, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported medication required, unexpected medical intervention and delay to treatment/therapy were results of case-specific circumstances there is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12033618
• MDR Text Key: 257209641
• Report Number: 2024168-2021-05204
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• 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: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2022
• Device Catalogue Number: SGC0705
• Device Lot Number: 10112U133
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CDS LOT 10128U160; SWARTZ SHEATH; CDS LOT 10128U160; SWARTZ SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Weight: 44