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

Catalog Number SGC0302

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Thrombosis (2100)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 filed to report thrombus and hypersensitivity.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.When the steerable guide catheter (sgc) was introduced into the right atrium (ra), a large thrombus was noticed on the tip of the sgc.The sgc was removed, flushed again and prepped for the instructions for use (ifu).The sgc was re-inserted into the ra, but a new thrombus appeared on the tip of the sgc.Activated clotting time (act) at the time was 380 with 12,000 units of heparin.It was noted that the thrombus was able be reversed with heparin.However, due to the reoccurring thrombus, the physician decided to discontinue the procedure.Mr remained at a grade of 4.It was noted that the patient may have been allergic to the hydrofluoric coating on the sgc.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported issue could not be tested via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information provided a conclusive cause for the reported thrombosis and hypersensitivity cannot be determined.The reported patient effect of thrombosis and hypersensitivity, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product 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: 9428578
• MDR Text Key: 169729308
• Report Number: 2024168-2019-14236
• Device Sequence Number: 1
• Product Code: DRA
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90514U213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR