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

Catalog Number SGC0101

Device Problems Difficult to Remove (1528); Device Slipped (1584); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The steerable guide catheter was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The clip delivery system referenced is being filed under a separate medwatch mfr number.

Event Description

This is filed to report the difficult retraction of the steerable guiding catheter (sgc), which has the potential to contribute to patient injury.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds) was advanced to the left atrium.During an attempt to position the clip, steering was a challenge due to a small atrium and poor imaging.Due to the positioning difficulty, the clip came in contact with the atrial wall.The steerable guide catheter (sgc) was slightly retracted, but the sgc came back into the right atrium.An attempt was made to re-advance the sgc back into the left atrium; however, resistance was noted.It appeared that the septal tissue was trapped between the tip of the sgc and cds shaft.The clip was confirmed to be fully closed and was attempted to be retracted into the sgc; however, the septal tissue prevented the clip from going into the sgc.The system was retracted as a single unit; however, resistance was felt, as both devices were caught in the septal tissue.The physician then pulled hard on the sgc and cds, and the devices were removed.During retraction, the clip then caught in the tissue tract and became inverted.After removal, it was observed that the clip was detached from the cds, and there was tissue on the clip.The procedure was aborted and post procedure mr remained at grade 4.The patient was confirmed to be clinically stable.Another mitraclip procedure was scheduled on 09/16/2015.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).The incident information provided to abbott vascular, analysis of the returned device, manufacturing records and complaint history for the reported lot were reviewed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a query of the complaint-handling database was performed and identified no other incidents reported for difficulty removing the device, physical resistance, or slippage of the device from this lot.The reported slippage of the device could not be confirmed via returned device analysis.The reported difficulty removing the device and physical resistance could not be replicated in a testing environment, as the reported events were based on procedural conditions due to the device encountering the septal tissue.The investigation concluded that the reported slippage of the device was related to user technique/procedural conditions.In addition, the reported physical resistance and difficulty removing the device was determined to be related to patient anatomy due to the device interacting and becoming caught on the septal tissue.Based on the information reviewed, 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: 5072025
• MDR Text Key: 26062557
• Report Number: 2024168-2015-05287
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112239
• 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
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: SGC0101
• Device Lot Number: 50605U307
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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