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

Model Number SGC0701

Device Problems Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2019

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The cds-ntw referenced was filed under mfr# 2024168-2020-00552-00.

Event Description

This is filed to report the torn soft tip observed on the returned steerable guide catheter (sgc) which was used with the first clip delivery system (cds).It was reported that this was a mitraclip procedure to treat grade 4 mixed etiology mitral regurgitation (mr).The sgc and the ntw cds were advanced to the left atrium via right groin access without issue.There was difficulty opening the clip, but the clip popped open and the clip had detached from the cds.It was decided to remove the cds with the clip.The clip was retracted to the sgc tip via the lock line.Left groin access was then obtained and a guide wire was advanced across the septum next to the sgc.A 14 french balloon dilatation catheter (bdc) was advanced to the septum and dilated the septum to allow for passage of the open clip.The bdc was removed and the sgc was retracted with the open clip across the septum into the right atrium and down to the groin.A new sgc and new cds were advanced to the left atrium via the left groin access.The mitral valve was treated and mr was reduced to grade 1 with the single clip.The atrial septal defect was closed with a septal occluder.The first sgc and clip were then fully removed from the patient via the right groin.Pressure was applied and the access sites were sutured.The patient is doing great.The following day, the patient was discharged home from the hospital with mr grade 1.No additional information was provided.

Manufacturer Narrative

The steerable guide catheter (sgc) was returned.The sgc soft tip was noted to be deformed during returned device analysis.The deformed sgc soft tip appears to be due to procedural circumstances.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 other complaints reported from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.H6: device code 4008 was removed and replaced with device code 2889.

• Brand Name: MITRACLIP G4 STEERABLE GUIDE CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9639834
• MDR Text Key: 177379574
• Report Number: 2024168-2020-00958
• 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: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2020
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 91024U222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 01/28/2020
• Supplement Dates Manufacturer Received: 02/11/2020
• Supplement Dates FDA Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CDS0701-NTW.
• Patient Age: 68 YR
• Patient Weight: 73