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

Catalog Number SGC0301

Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

Patient Problem Intimal Dissection (1333)

Event Date 10/03/2018

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 steerable guide catheter was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the small dissection in the iliac vein.It was reported that this was a mitraclip procedure to treat grade 4 degenerative mitral regurgitation (mr).The first steerable guide catheter (sgc) was inserted through the femoral vein access site, but could not be advanced past the lower iliac.Resistance was met and the sgc would not advance further.The sgc was removed and the curved segment of the sgc was accordioned.A 20 (b)(6) sheath was inserted and a stiffer wire was advanced without issue.These were then removed and a new sgc was inserted, but could not advance past the same location on the iliac.The second sgc was removed and no damage was noted on the sgc as less force was applied and less time was spent trying to advance.A venogram was performed which found an obstruction/mass in the iliac.A small dissection in the iliac was also noted, but did not require treatment as it was stable.The cause of the dissection is unknown.The mitraclip procedure was aborted and the heparin was reversed with medication.The doctor did not want to try the other femoral vein until a ct scan of the lower iliac veins is performed.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Review of the complaint history found no similar incidents reported from this lot.The reported failure to advance and kinked shaft appears to be related to patient morphology/pathology.The reported patient effect of intimal dissection as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.A definitive cause for the intimal dissection cannot be determined.It is possible that the dissection was related to the multiple attempts to advance the steerable guide catheter; however, this cannot be confirmed.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
• 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: 7995386
• MDR Text Key: 124700912
• Report Number: 2024168-2018-08103
• Device Sequence Number: 1
• Product Code: DRA
• 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,Followup
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2019
• Device Catalogue Number: SGC0301
• Device Lot Number: 80605U124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: 20 F COOK SHEATH, STIFF GUIDE WIRE
• Patient Outcome(s): Required Intervention