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 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Evaluation summary: all available information was investigated and the sgc (steerable guide catheter) was noted to have a torn soft tip. Tears in the soft tip is indicative of an interaction between the clip and sgc tip during retraction; however, the analysis was unable to replicate the difficulty retracting the clip into the returned sgc. A review of the lot history record revealed no manufacturing nonconformities. Additionally, a review of the complaint history identified no other incidents reported from this lot. All available information was investigated and a definitive cause for the tear in the soft tip could not be determined. Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, or labeling of the device.

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. 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 torn soft tip found during returned device analysis. There was no reported device issue; however, the steerable guide catheter was returned with a torn, but intact, soft tip.

• 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: 7170131
• MDR Text Key: 128305909
• Report Number: 2024168-2018-00136
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 01/25/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/01/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70801U145
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial