MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0302

Device Problems Difficult or Delayed Positioning (1157); Deformation Due to Compressive Stress (2889)

Patient Problem Thrombosis (2100)

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.The other steerable guide catheter is being filed under a separate medwatch report.

Event Description

This is filed to report the thrombus requiring aspiration.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.The steerable guide catheter (sgc 0302/80925u119) was inserted and advanced to the right atrium (ra) when thrombotic material was noted on the tip of the dilator and the shaft of the sgc.The devices were removed under aspiration.During re-prepping the sgc, a kink was noted at the end of the guide therefore the device was not used again.Additional heparin was administered and a second sgc was advanced without issue.The physician noted the second sgc (sgc 0302/81006u134)advanced smoother than the first sgc.When the sgc reached the ra, thrombotic material was seen at the shaft of the guide, tip of the dilator, and guide wire in the left atrium (la).The devices were removed under aspiration and the procedure aborted with the mr remaining at 3-4.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: all available information was investigated, and the reported issues of bent and kink were confirmed via returned device analysis.The reported physical resistance could not be replicated under testing environment.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.All the available information was investigated and the definitive cause for the reported physical resistance could not be determined.The reported bent and kink appears to be cascading effects of physical resistance.The reported patient effect of thrombosis as listed in the mitraclip system instructions for use (ifu), is known possible complications associated with mitraclip procedures.A definitive cause for thrombosis could not be determined.There is no indication of product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8410542
• MDR Text Key: 138504810
• Report Number: 2024168-2019-01917
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80925U119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Date Manufacturer Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention