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

Catalog Number SGC0101

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2016

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 is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.The clip delivery system referenced is filed under a separate medwatch report.

Event Description

This is filed for damage to the soft tip of the steerable guide catheter, which has the potential to cause or contribute to patient injury.It was reported that the patient, with functional mitral regurgitation (mr), underwent a mitraclip procedure.It was noted that the septum was very thick; therefore, the transseptal puncture was suboptimal.The steerable guide catheter (sgc) was advanced and the clip delivery system (cds) was inserted.Attempts were made to position the clip appropriately above the mitral valve; however, the transseptal puncture was deemed too posterior.Troubleshooting maneuvers to position the clip were unsuccessful, so it was decided to remove the devices and perform a second transseptal puncture.During removal of the cds, the clip caught on the tip of the sgc and bent and the tip of the sgc tore, but the devices were successfully removed.A new transseptal puncture was performed and two clips were implanted successfully, with the mr reduced from grade 4 to grade 2.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and investigated.The reported steerable guide catheter (sgc) torn soft tip was confirmed.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and the reported torn material was a result of the clip getting caught on the guide tip; therefore, appears to be related to procedural conditions.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• 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: 5890906
• MDR Text Key: 52723515
• Report Number: 2024168-2016-05569
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60426U239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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 Age: 77 YR
• Patient Weight: 68