MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number SGC0302

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 09/16/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4) - permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The customer reported the steerable guide catheter 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 vein laceration.It was reported this was a mitraclip procedure to treat mitral regurgitation (mr).During advancement of the non-abbott guide wire, the vein was noted to be kinking.The steerable guide catheter (sgc) was inserted into the anatomy and the patient became hemodynamically unstable.Imaging showed a laceration in the iliac vein, probably caused by the non-abbott wire and possibly worsened by the advancement of the sgc.The procedure was aborted, no clips were implanted.The laceration was stented.The patient was stabilized.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of hypotension and perforation, as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.Based on the information provided, the hypotension and perforation were likely caused by the non-abbott wire and possibly worsened by the advancement of the steerable guide catheter (sgc) and were a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9163016
• MDR Text Key: 161424198
• Report Number: 2024168-2019-12386
• 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
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90312U149
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON-ABBOTT AMPLATZ WIRE; NON-ABBOTT AMPLATZ WIRE
• Patient Outcome(s): Required Intervention