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

Model Number N/A

Device Problem Difficult to Advance (2920)

Patient Problem Perforation (2001)

Event Date 02/21/2022

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.

Event Description

This is filed to report the dissection of the interatrial septum.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 2-3.The atrial septal puncture was performed near the posterior margin of the fossa ovalis.The patient had a hard fossa ovalis and it was difficult to advance the steerable guide catheter (sgc) through to the left atrium (la).The fossa ovalis stretched and tension and torque were applied to the sgc allowing it to pass through.The procedure continued with one mitraclip successfully implanted centrally on a2/p2.After removing the sgc a left-to-right shunt was noted.In addition, a dissection cavity (depth 15mm and width 5mm) on the posterior wall of the interatrial septum could be seen.There was no leak and no increase in pressure.Therefore, intervention was not warranted, and the procedure was complete with a final mr grade of 1.There was no clinically significant delay in the procedure and no adverse patient sequalae.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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation determined the reported difficult to advance the steerable guide catheter (sgc) to the left atrium appears to be related to patient morphology/pathology.The perforation appears to be due to the difficulty advancing the device.Perforation is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13791248
• MDR Text Key: 287324766
• Report Number: 2024168-2022-02704
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: N/A
• Device Catalogue Number: SGC0705
• Device Lot Number: 10902R157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/17/2022
• Supplement Dates Manufacturer Received: 03/24/2022
• Supplement Dates FDA Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 50 KG
• Patient Race: Asian