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

Catalog Number SGC0302

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). All available information was investigated and the reported steerable guide catheter (sgc) torn soft tip was confirmed. A review of the lot history record revealed no manufacturing nonconformities. Additionally, a review of the complaint history identified no similar incidents reported from this lot. All available information was investigated and the reported clip getting caught on the guide tip, resulting in the identified tears in the soft tip appears to be related to user technique due to the physician retracting the clip delivery system (cds) quickly. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

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

Event Description

This report is filed for tears in the steerable guide catheter tip. It was reported that this was a mitraclip procedure treating functional mitral regurgitation (mr) grade 4. The clip delivery system (cds) was advanced to the left atrium and was steered down into position. Following, the on attempt to open the clip, the clip was unable to open. Troubleshooting maneuvers were performed, however, this clip would still not open. An attempt was made to quickly remove the cds; however, during removal, the clip was hanging at the tip of the steerable guide catheter (sgc). The clip was unable to be freed from the sgc tip and was still unable to open. The cds and sgc were removed as a single unit at the groin site via a surgical procedure. Following, sgc tip tears were noted. Reportedly, the tears were due to the clip attachment to the sgc tip. There was a delay reported; however, there were no associated clinical symptoms. The mr remined grade 4. Reportedly, the patient had no subsequent problems and another mitraclip procedure will be performed in 6-8 weeks. There was no additional information provided regarding this issue.

• 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: 6926319
• MDR Text Key: 248213086
• Report Number: 2024168-2017-08013
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/25/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70424U307
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/02/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial