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

Catalog Number SGC0302

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is conservatively filed to report a potential breach in sterility.It was reported that during device preparation of the steerable guide catheter (sgc), the nurse noticed a hole in her glove after her hand was inside the bowl of heparinized water.After informing the physician of the potential breach in sterility, the decision was made to use a new bowl of heparinized water, disinfect the sgc tip, and use the sgc for the procedure.The procedure was performed without issue and the functional mitral regurgitation (mr) was reduced from grade 3-4 to grade 1-2.There was no reported adverse patient sequela or a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.It should be noted that the mitraclip instructions for use (ifu) states the mitraclip nt device should be implanted with sterile techniques.Failure to follow these instructions, warnings and precautions may lead to device damage, user injury, or patient injury.Use universal precautions for biohazards and sharps while handling the mitraclip nt system to avoid user injury.Based on the information reviewed, the incorrect method appears to be a case of user error deviating from the ifu.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: 7585131
• MDR Text Key: 110727511
• Report Number: 2024168-2018-04353
• 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: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80222U122
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM