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

Catalog Number SGC0301

Device Problems Difficult to Insert (1316); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: all available information was investigated and the and the reported difficult to insert was confirmed due to the observed torn silicone valve of the steerable guide catheter (sgc).A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and based on the information review and the result of the returned device analysis, the reported inability/difficulty inserting the cds clip introducer into the sgc appears to be due to the observed torn sgc silicone valve; however, how the silicone valve got torn, cannot be confirmed.It is possible that the user technique during device preparation resulted in the torn silicone valve; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This report is filed as returned device analysis found a tear on the steerable guide catheter (sgc) silicone valve.It was reported that during a mitraclip procedure the steerable guide catheter (sgc) was advanced in the anatomy and placed without issues.The clip delivery system (cds) was attempted to be inserted; however, the sgc would not take the cds clip introducer.The cds was removed without reported issues and without any damage.The sgc was removed and a new sgc was advanced in the anatomy.The same cds was advanced and the procedure was successfully completed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided regarding this issue.The device returned as torn material on the silicone valve was observed on 02-nov-2018.

• 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: 8061138
• MDR Text Key: 127242205
• Report Number: 2024168-2018-08703
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2019
• Device Catalogue Number: SGC0301
• Device Lot Number: 80619U154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• 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 Age: 74 YR
• Patient Weight: 85