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

Catalog Number SGC0702

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 12/16/2020

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 xt clip referenced was filed under medwatch report number 2024168-2021-00122-00 and the nt clip referenced was filed under 2024168-2021-00125-00.

Event Description

This is filed to report a tear in the silicone valve of the sgc.It was reported that the index mitraclip procedure was performed on (b)(6) 2012 to treat functional mitral regurgitation (mr) with grade 4.One clip was implanted, reducing mr 2.On (b)(6) 2020, a procedure was performed to treat normal development of the disease, mr jets in the medial and lateral position of the previous clip implanted in 2012.The first clip was implanted without problems and leaflet insertion assessment was performed per the instruction for use (ifu).After a couple of minutes, the clip appeared to have a single leaflet device attachment (slda).The clip had detached from the posterior leaflet.It was decided to implant another clip medial to solve the medial jet.The clip was placed and during deployment sequence, the lock line was pulled out approximately 25 cm and would not retract any further.The lock line did not work.Therefore, it was decided to deploy the clip and remove the lock line as part of the deployment.During this maneuver, the clip was opened and inverted, and it was decided to remove the clip to avoid embolism of the clip.A vascular surgeon was required to remove the clip from the vein.Mr remained the same.The patient remained stable and was recovering from the minimal vascular intervention.Device analysis of the returned steerable guide catheter found that the silicone valve was torn and flush port was broken.Additional information reported that the valve damage was due to the clip being extracted by the physician at the end of the procedure.No additional information was provided.

Event Description

(revised description) it was reported that the index mitraclip procedure was performed on 05/22/2012 to treat functional mitral regurgitation (mr) with grade 4.One clip was implanted, reducing mr 2.On (b)(6) 2020, a procedure was performed to treat normal development of the disease, mr had increased to 4+, there were mr jets in the medial and lateral position of the previous clip implanted in 2012.The first clip (cds0702-xt, 00901u114) was implanted without problems and leaflet insertion assessment was performed per the instruction for use (ifu).After a couple of minutes, the clip appeared to have a single leaflet device attachment (slda).The clip had detached from the posterior leaflet.It was decided to implant another clip (cds0702-nt, 00902u220) medial to solve the medial jet.The clip was placed and during deployment sequence, the lock line was pulled out approximately 25 cm and would not retract any further.The lock line did not work.Therefore, it was decided to deploy the clip and remove the lock line as part of the deployment.During this maneuver, they tried to open the clip and did not open.It was decided to remove the clip to avoid embolism of the clip.A vascular surgeon was required to remove the clip from the vein.Mr remained the same at 4+.The patient remained stable and was recovering from the minimal vascular intervention.Device analysis of the returned steerable guide catheter found that the silicone valve was torn, and flush port was broken.Additional information reported that the valve damage was due to the clip being extracted by the physician at the end of the procedure.Additional information received reporting that on 01/27/2021 an additional procedure was performed to place the additional clip that the physician wanted to implant in the medial position of the valve on (b)(6) 2020.The clip was implanted, reducing mr from 4+ to 3.There was no issue during the procedure or allegation against the clip used.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported material split/torn was confirmed during returned device analysis as steerable guide catheter silicone valve was noted to be torn.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.All available information was investigated, and the reported material tear (silicone valve) and the observed steerable guide catheter (sgc) soft tip tear were due to procedural circumstances/ operational context.Moreover, there were no issues reported with the sgc flush port throughout the procedure.Therefore, the observed broken flush port was likely an outcome of user technique/procedural circumstances related to handling of the device.Based on the information reviewed, 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: 11293667
• MDR Text Key: 232188180
• Report Number: 2024168-2021-00941
• 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: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2021
• Device Catalogue Number: SGC0702
• Device Lot Number: 00902U151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 IMPLANTED MITRACLIP