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

Catalog Number SGC0302

Device Problems Difficult To Position (1467); Device Slipped (1584)

Patient Problem Atrial Perforation (2511)

Event Date 05/29/2018

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 additional relevant information.The clip delivery system referenced is filed under a separate medwatch report number.

Event Description

This is filed to report the torn septum.It was reported that this was a mitraclip procedure to treat grade 4 functional mitral regurgitation (mr).There were difficulties maneuvering due to the floppy septum.The steerable guide catheter (sgc) was slipping out of position in the atrium.The first clip delivery system (cds) was inserted, but it was removed with the unemployed mitraclip after the shaft was noted to have become twisted during maneuvering.The procedure continued with another cds and two mitraclips were implanted reducing mr to grade 3 to 4; however, it was a very long procedure.After removal of the sgc, the septum was noted to have torn.There have been no patient symptoms related to the septal tear.No treatment has been planned for the tear.There was no additional information provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Review of the complaint history identified no other incidents reported from this lot.The investigation determined the reported slippage of the device and difficulty positioning the device appears to be related to the floppy septum.The reported patient effect of atrial perforation as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures and appears to be a result of procedural conditions (retrieving the steerable guide catheter).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: 7616180
• MDR Text Key: 111616347
• Report Number: 2024168-2018-04639
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80219U248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 80