MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number SGC0301

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 09/04/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow-up will be submitted with all relevant information.

Event Description

This is filed to report thrombus.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with a grade of 4.The steerable guiding catheter (sgc) was advanced and the first clip was implanted, reducing mr to 2.Thrombus was seen at the superior vena cava.The activated clotting time (act) was 317 seconds.No additional clips were implanted.The patient was put on medication and on (b)(6) 2019 the patient was doing well.It cannot be determined if the sgc caused or contributed to the thrombus.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of thrombosis as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9111740
• MDR Text Key: 162001469
• Report Number: 2024168-2019-12053
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• 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: 10/29/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90716U250
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: 10/17/2019
• Supplement Dates FDA Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR