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

Model Number SGC0701

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

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 06/03/2021

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 the perforation.It was reported this was a mitraclip procedure to treat grade 2 functional mitral regurgitation (mr).The steerable guide catheter and mitraclip delivery system were inserted.During the procedure the patients¿ blood pressure dropped and required medical support.The patient was checked for external bleeding but none was noted.One clip was implanted and mr was reduced to <1.After the mitraclip procedure, the patient was re-evaluated.Contrast was used in the right femoral vein and a small venous puncture was observed approximately 6 inches from the access site.A balloon was advanced into the femoral vein, the balloon was expanded at the site of the puncture and was left in place for two minutes to apply pressure at the site.The patient was stable, extubated and was sent to the coronary care unit.A blood transfusion was recommended.Per the physician, it is suspected the puncture occurred when dilating the groin or inserting the guidewire for the transseptal puncture; however, this cannot be confirmed.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.Perforation, hemorrhage and hypotension are listed in the instructions for use as known possible complications associated with mitraclip procedures.The investigation determined the reported perforation appears to be related to procedural conditions.The hemorrhage and subsequent hypotension appear to be a result of the perforation.The reported medication required and unexpected medical interventions 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: 12045280
• MDR Text Key: 257856805
• Report Number: 2024168-2021-05290
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• 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: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10120U213
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP(X1)
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 80