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

Catalog Number SGC0301

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Atrial Perforation (2511)

Event Date 01/31/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The additional clip delivery system referenced is being filed under separate medwatch report.

Event Description

This is filed to report the torn septum, requiring intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.One xtr mitraclip was implanted.It was then noted that the septum was torn and there was no support for the steerable guide catheter (sgc).The second clip delivery system (cds) was advanced to the mitral valve; however, difficulty was met during deployment due to the low transseptal puncture.Troubleshooting was performed for 20 minutes and the clip was able to be deployed.The torn septum was treated with a percutaneous device.Two clips were implanted, reducing the mr to 3.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).The device was not returned for analysis.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 incidents reported from this lot.All available information was investigated and reported physical resistance appears to be related to patient morphology/pathology due to the difficult transseptal puncture.The atrial perforation was a result of procedural conditions.The reported patient effects of cardiac perforation (atrial perforation) is listed in the mitraclip system instructions for use as a known possible complication associated with mitraclip procedures.There is no indication of a 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: 8367645
• MDR Text Key: 137060880
• Report Number: 2024168-2019-01416
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2019
• Device Catalogue Number: SGC0301
• Device Lot Number: 81020U147
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED CLIP; 1 IMPLANTED CLIP
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 56