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 Hematoma (1884); Perforation (2001)

Event Date 03/09/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation; the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The mitraclip device referenced is filed under separate medwatch report number.Na.

Event Description

This is filed to report the perforation worsened during use of the steerable guide catheter.It was reported this was a mitraclip procedure performed to treat mixed mitral regurgitation (mr) grade 4.When gaining access, the needle that was used perforated the artery.When the steerable guide catheter (sgc) was advanced, the perforation in the artery worsened.The clip delivery system (cds) were advanced.Clip deployment was started; however, after retracting the lock line about 6-7mm, the lock line was stuck inside the handle.After pulling on the lock line several times, the lock line was able to be removed.The clip was implanted, reducing mr to 2-3.The cds was removed and examined.There were no knots or kinks on the line.Upon removal of the device from the groin; a hematoma was observed as a result from the perforation.The hematoma was treated surgically.Hospitalization was prolonged due to the surgical treatment of the artery.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.The reported patient effects of perforation and hematoma as listed in the mitraclip g4 system instructions for use (ifu), are known possible complications associated with mitraclip procedures.Based on this information, the reported perforation was due to procedural conditions as the needle that was used to gain access created the perforation and the sgc insertion worsened it.The reported hematoma was a result of the reported perforation.The reported surgical intervention (minor surgery) and delay to therapy/treatment were a result of case specific circumstances as the hematoma was treated surgically and the hospitalization was prolonged due to the surgical treatment of the artery respectively.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: 11606491
• MDR Text Key: 243583007
• Report Number: 2024168-2021-02667
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 01222U158
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 110