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

Catalog Number SGC0301

Device Problems Device Damaged by Another Device (2915); Difficult to Advance (2920)

Patient Problem Perforation (2001)

Event Date 04/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the clip was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The proglide closure devices referenced are being filed under separate medwatch reports.

Event Description

This is filed to report the perforation and medical intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4, with a papillary muscle rupture.Right femoral vein was accessed and prepared with two pro glide closure devices prior to inserting the steerable guide catheter (sgc).The sgc was inserted into the vein over a non-abbott wire; however, resistance met during advancement.Fluoroscopy showed the proglide device was entangled on the sgc, causing the non-abbott wire to become kinked.It is unknown if the cause of resistance was the proglide closure devices or the non-abbott wire.The proglide devices were removed, and the sgc was removed over the wire.The non-abbott wire was cut with wire cutters and subsequently removed.A veinogram revealed the femoral vein had a small perforation.The perforation was bleeding and it was contained; pressure was applied to control bleeding.The sgc was flushed and re-advanced to the mitral valve to continue with the procedure.Two clips were implanted, reducing mr to 2.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).The device was not returned for analysis.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 the reported device damaged by another device resulting in difficult to position appears to be related to the user technique/procedural circumstances.The reported patient effect of perforation is listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.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: 8628047
• MDR Text Key: 145647207
• Report Number: 2024168-2019-03968
• 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: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90108U233
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2019
• Initial Date FDA Received: 05/21/2019
• Supplement Dates Manufacturer Received: 07/25/2019
• Supplement Dates FDA Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (2) PROGLIDE CLOSURE DEVICES; (2) PROGLIDE CLOSURE DEVICES
• Patient Outcome(s): Required Intervention