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

Catalog Number SGC0302

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Low Blood Pressure/ Hypotension (1914); Atrial Perforation (2511)

Event Date 11/20/2018

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 device was discarded.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 perforation requiring a transfusion.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The patient became unstable after the steerable guide catheter (sgc) was introduced to the fossa.There were problems due to a kinked femoral vein, but the sgc was able to be advanced.While pushing the sgc through the fossa, the guide wire in the left atrium and the sgc were lost.The patients blood pressure decreased and a perforation was noted; therefore, the sgc was removed and a transfusion was performed.Prolonged hospitalization was needed.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 identified 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 physical resistance leading to device operates differently than expected appears to be related due to patient pathology/morphology (kinked femoral vein).The reported cardiac perforation appears to be related due to procedural circumstances (pushing of sgc).The reported hypotension can be a cascading effect of perforation, however definitive cause could not be determined in this case.The reported patient effects of hypotension and cardiac perforation (atrial perforation) as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initially filed medwatch, additional information received noted the patient was sent to surgery for treatment, and discharged home a few days later.No additional information was provided.

• 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: 8151286
• MDR Text Key: 129932766
• Report Number: 2024168-2018-09533
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80824U260
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE; GUIDE WIRE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 88 YR