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

Catalog Number SGC0301

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Atrial Perforation (2511)

Event Date 06/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the steerable guide catheter was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report the large atrial septal defect (asd).It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.During the procedure, the steerable guide catheter (sgc) slipped from the left atrium (la) to the right atrium (ra) two times.The sgc was re-advanced to the la without issue.Three clips were implanted, reducing the mr to 2.After the sgc was removed, a large atrial septal defect was noted, which was treated with an asd occluder.The patient had a good outcome.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.The reported patient effect of atrial septal defect (asd), as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.All available information was investigated and the reported steerable guide catheter (sgc) slipping back into the right atrium (ra) appears to be related to user technique, as the device was inadvertently moved.The reported patient effect of asd is likely procedurally related, as the sgc is advanced through the septum in order to gain access to the left atrium (la) for positioning over the valve.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
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6681412
• MDR Text Key: 78833232
• Report Number: 2024168-2017-05559
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/13/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2018
• Device Catalogue Number: SGC0301
• Device Lot Number: 70206U126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 07/10/2017
• Supplement Dates FDA Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP (3)
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 79