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

Catalog Number SGC0702

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 12/14/2020

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 pericardial effusion and 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 severely dilated left atrium and challenging view of the superior/posterior position to achieve adequate tenting.The transseptal puncture was performed and the steerable guide catheter (sgc) was able to cross the septum without issue.However, 15-20 minutes later, the blood pressure dropped and a pericardial effusion (pe) was observed.Protamine doses was administered and pericardiocentesis was performed to treat the pe.The procedure was aborted.The patient is stable and was transferred to recovery.No clips were implanted, and mr is 4.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 the reported event.Based on the available information, a cause for the reported hypotension and pericardial effusion could not be determined.Additionally, reported hypotension and pericardial effusion are listed in the instructions for use as known possible complications associated with mitraclip procedures.The additional therapy / non-surgical treatment and treatment with medication(s) were the result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.Na.

• 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: 11123986
• MDR Text Key: 225297246
• Report Number: 2024168-2021-00115
• 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: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2021
• Device Catalogue Number: SGC0702
• Device Lot Number: 00910U131
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention