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

Model Number SGC0701

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)

Patient Problem Thrombosis (2100)

Event Date 09/11/2020

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

This is being filed to report the thrombus.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with grade 4.After transseptal puncture was achieved, the steerable guide catheter (sgc) was advanced to the left atrium where thrombus was noticed.The sgc was retracted back into the right atrium and the thrombus was brought back into the right atrium as well.It was suspected that the thrombus was brought back up from the groin as there was no evidence of thrombus during pre-procedural imaging or during transseptal puncture.The physician decided to abort the procedure and administer anticoagulants to the patient and bring back at a later date.No additional information was provided.

Manufacturer Narrative

The device was returned.All available information was investigated.The returned device analysis found that the steerable guide catheter (sgc) soft tip was noted to have a 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 similar incidents reported from this lot.A cause for the sgc hemostasis valve soft tip tear could not be determined.The reported thrombosis appears to be due to a combination of patient and procedural conditions.The reported patient effect of thrombosis is listed in the instruction for use (ifu) as a known possible complication associated with mitraclip procedures.The reported treatment with medications was due to case specific circumstances.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: 10635293
• MDR Text Key: 210000832
• Report Number: 2024168-2020-08284
• 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: 11/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00711U106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention