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

Catalog Number SGC0702

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)

Event Date 06/25/2021

Event Type  Injury  

Manufacturer Narrative

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 filed to report tissue damage, surgical intervention and prolonged hospitalization it was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.It was noted enlarged atrium.There was resistance with the anatomy when the steerable guide catheter (sgc) was inserted through the inguinal region.Therefore, the sgc was expanded with a 20fr dilator and the sgc was re-inserted.The sgc was able to be advanced to the mitral valve, and the clip was deployed.After the sgc was removed without issues, the blood pressure dropped.A pressor agent was administered to stabilize the blood pressure.The patient remained hospitalized.One clip was implanted, reducing mr to 2.The next day, it was discovered that the iliac vein was damaged; and therefore, the vein was surgically treated.The patient is stable.There was no 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 similar complaints reported from this lot.The investigation was unable to determine a cause for the reported resistance with anatomy.The perforation appears to be related to the resistance with anatomy.The hypotension appears to be related to the perforation.Perforation and hypotension are listed in the instructions for use as known a possible complication associated with mitraclip procedures.The reported medication required, hospitalization and surgical intervention were results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

N/a.

• 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: 12197128
• MDR Text Key: 262469890
• Report Number: 2024168-2021-06222
• 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: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10210U122
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 50