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

Catalog Number SGC01ST

Device Problem Failure to Advance (2524)

Patient Problem Perforation (2001)

Event Date 05/18/2016

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 additional relevant information.

Event Description

This is filed to report that during advancement of the steerable guiding catheter (sgc), resistance was felt and the groin artery was injured/bleeding.The bleeding was treated with a surgical suture.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.The steerable guiding catheter (sgc) was advanced approximately 5 cm into the anatomy; however, resistance was noted with the anatomy and the groin artery was perforated.The physician stated that this might have been occurred due to an unusual pathway of the vein and artery.The procedure was aborted.No clips were implanted and the mr remained at 3.A vascular surgeon stopped the bleeding with a surgical suture.It was confirmed that the patient was in stable hemodynamic condition after procedure.A new mitraclip procedure has been planned in the next month.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.All available information was investigated and the reported failure to advance the steerable guiding catheter (sgc) appears to be related to the challenging patient anatomy.The reported perforation was likely related to procedural conditions due to sgc insertion.The reported surgical procedure, additional therapy/non-surgical treatment, and hospitalization were a result of case-specific circumstances, as the perforation was treated with a surgical suture, and a second mitraclip procedure was performed on a later date to treat the mitral regurgitation.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 other incidents reported from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.

Event Description

Subsequent to the initial report filed, the following information was provided: the perforation was caused by the transseptal puncture, and the steerable guiding catheter (sgc) worsened the perforation.On (b)(6) 2016, a second mitraclip procedure was performed.One clip was implanted, successfully reducing the mr from 3 to 1.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
• 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: 5704269
• MDR Text Key: 46734967
• Report Number: 2024168-2016-03711
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: SGC01ST
• Device Lot Number: 60105U150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• 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): Hospitalization; Required Intervention; Disability