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 Perforation (2001); Pericardial Effusion (3271)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 pericardial effusion and perforation.It was reported this was a mitraclip procedure to treat grade 4 degenerative mitral regurgitation (mr).The steerable guide catheter and mitraclip delivery system were inserted.A pericardial effusion was noted, there was a 2 mm perforation in the atrium wall.Per the physician, the perforation was caused by the dilator.The procedure was aborted, 700 ml of blood was drained and the patient was taken to surgery for surgical repair of the perforation and mitral valve replacement surgery.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.It should be noted that the reported patient effects of perforation and pericardial effusion, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Based on the information provided, the reported patient effects and subsequent treatment/surgery and hospitalization were due to procedural 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: 9169867
• MDR Text Key: 162330316
• Report Number: 2024168-2019-12447
• 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: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90703U117
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MITRACLIP DELIVERY SYSTEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR