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 03/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Internal file number - (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 yet complete. A follow up report will be submitted with all relevant information.

Event Description

This report is filed due to a soft tip tear in the steerable guide catheter. The steerable guide catheter (sgc) was used during a mitraclip procedure with no reported complaint against this device. Reportedly the sgc soft tip was not torn. Subsequently, the sgc was returned to abbott vascular. Initial analysis of the returned sgc, done on (b)(6) 2018, noted that the soft tip of the sgc was torn. All soft tip material seemed to be present. There was no reported adverse patient effect due to the soft tip tear. No additional information was provided regarding this sgc issue.

Manufacturer Narrative

(b)(4). Evaluation summary: all available information was investigated and the steerable guide catheter (sgc) was noted to have a soft tip tear. The observed torn soft tip was a result of the clip getting caught on the guide tip; therefore, attributed to procedural conditions. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this complaint. Additionally, a review of the complaint history identified no other incident reported from this lot. 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
• MDR Report Key: 7511518
• MDR Text Key: 108246516
• Report Number: 2024168-2018-03546
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/06/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 71205U214
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/30/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 05/14/2018 Patient Sequence Number: 1

Treatment

MITRACLIP CLIP DELIVERY SYSTEM