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

Catalog Number SGC0302

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 other incidents reported from this lot.All available information was investigated and the reported torn sgc soft tip appears to be related to procedural conditions and a secondary effect of the clip becoming caught on the tip during removal.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.The clip delivery system referenced is being filed under a separate medwatch report.

Event Description

This is filed to report the damaged steerable guide catheter (sgc) soft tip.It was reported that the patient, with functional mitral regurgitation (mr), underwent a mitraclip procedure.The transseptal puncture was made in a very superior and posterior position and in an extremely anterior direction, per physician choice.Due to the transseptal puncture, the sgc was directed toward the anterior wall of the left atrium.The clip delivery system (cds) was advanced, but was unable to properly straddle due to the position of the sgc.Several attempts were made to position the cds; however, the cds could not advance to straddle.The cds was removed; however, it was not checked if the clip was fully closed prior to pulling back into the sgc and the cds caught on the soft tip of the sgc.The cds and sgc were removed from the patient anatomy.The cds was not used again, as it was possible that the clip arms and grippers were damaged; although, no damage was noted.Additionally, the sgc was removed and it was noted that there was a tear in the soft tip of the sgc.The sgc and cds were replaced and the procedure continued with implantation of one clip, reducing the mr from grade 4 to grade <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: 6718792
• MDR Text Key: 80411272
• Report Number: 2024168-2017-05940
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K161985
• 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
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70309U121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• 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 Age: 72 YR
• Patient Weight: 68