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

Catalog Number SGC0302

Device Problems Break (1069); Positioning Failure (1158); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was returned.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 cable break and inability to straighten the steerable guide catheter (sgc) tip.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.Visualization was difficult due to anatomical challenges.The sgc and clip delivery system (cds) were advanced to the mitral valve; however, the +/- knob of the sgc would not hold position due to a cable break, and the tip of the sgc could not be straighten.Additionally, grasping was difficult with the cds due to the anatomical challenges.The devices were removed, and the procedure was discontinued.No clips were implanted, and the mr remained at 4.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: all available information was investigated the reported unable to straighten and cable break were confirmed via returned device analysis.The observed knob slippage could not be confirmed.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.Based on the information reviewed, the broken cables appear to be due to procedural circumstances (suboptimal visualization and operational context/user technique).The reported unable to curve the steerable guide catheter (sgc) and knob slippage were secondary effects of the reported cable break as with a broken cable, the shaft cannot be tensioned to curve or straighten when the knob is rotated.There is no indication of 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: 8312674
• MDR Text Key: 135726429
• Report Number: 2024168-2019-00906
• 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: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80814U111
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/05/2019
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 03/28/2019
• Supplement Dates FDA Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM
• Patient Age: 85 YR
• Patient Weight: 86