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

Catalog Number SGC01ST

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

Patient Problems Respiratory Distress (2045); Atrial Perforation (2511)

Event Date 09/29/2014

Event Type  Injury  

Event Description

This is submitted to report the atrial septal defect that was observed after use with the steerable guiding catheter, which was treated with an atrial septal defect device.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.One mitraclip was implanted successfully and the mr was reduced to 3.The next clip delivery system was advanced and the clip was implanted.The mr was reduced to 2, with two clips implanted.During removal of the steerable guide catheter, the patient developed hypoxia due to a right atrium shunt to the left atrium.The patient was treated with an atrial septal defect (asd) amplatzer device.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concommitant products: 2 implanted mitraclips.The customer reported the sgc was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).The incident information was reviewed; however, a failure analysis of the complaint device could not be performed because the product was not returned for analysis.Therefore, the analysis of this complaint will be an assessment of the manufacturing records/complaint history and information provided to abbott vascular.In this case, there was no reported device malfunctions associated with the cds.The reported patient effects of respiratory failure (hypoxia / respiratory distress) and mitral valve injury (atrial septal defect), as listed in the mitraclip system instructions for use (ifu) are known possible complications associated with mitraclip procedures.In this case, the atrial septal defect resulting in respiratory distress (hypoxia) was associated with the removal of the sgc during the procedure; therefore these reported events are associated with procedural conditions / operational context.There is no indication of a product quality deficiency with respect to manufacture, design, or labeling.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.Based on the information reviewed, there is no indication of a product deficiency.

• 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 462
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4189953
• MDR Text Key: 5093997
• Report Number: 2024168-2014-06856
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Catalogue Number: SGC01ST
• Device Lot Number: 10319305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 74