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

Catalog Number SGC0301

Device Problems Device Operates Differently Than Expected (2913); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The sgc was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The cds referenced is filed under a separate medwatch report number.

Event Description

This is filed to report the steerable guiding catheter (sgc) soft tip tear.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The sgc was advanced to the left atrium.When the clip delivery system (cds) was advanced for straddling, the sgc needed to be turned over 180 degrees to get a normal fluoroscopy view.It was determined that the sgc had an abnormal angle; therefore, the decision was made to replace the device.During removal of the cds, resistance was noted with the sgc tip.The cds was advanced back and forth a few times, and the cds was removed.The sgc was then removed, and it was noted that the soft tip was torn.A new sgc was successfully used with the same cds.Two clips were implanted, reducing the mr to 1.There was no clinically significant delay and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).The steerable guide catheter (sgc) was returned and investigated.The reported device operates differently than expected issue in this incident could not be confirmed; however, the reported torn material sgc soft tip was confirmed.A review of the lot history record revealed no manufacturing nonconformities issued to this lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.A definitive cause for the reported device operates differently than expected could not be confirmed as the return device analysis confirmed that the sgc functioned as intended.Additionally, the reported torn soft tip appears to be related to user technique/procedural conditions as the clip delivery system was advanced back and forth a few times resulting in the clip getting caught on the tip of the sgc, tearing the sgc tip.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• 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: 6380669
• MDR Text Key: 69367999
• Report Number: 2024168-2017-01836
• 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: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2017
• Device Catalogue Number: SGC0301
• Device Lot Number: 61202U150
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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: MITRACLIP SYSTEM, CLIP DELIVERY SYSTEM
• Patient Age: 70 YR
• Patient Weight: 102