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

Catalog Number SGC01ST

Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017); 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.(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report that returned device analysis indicates that the soft tip of the steerable guide catheter (sgc) may have torn and separated, which has the potential to cause or contribute to patient injury.It was reported that the mitraclip was used in the tricuspid valve and was unable to grasp the leaflets.The procedure was completed without any mitraclips implanted.There were no adverse patient effects.Returned device analysis of the clip delivery system (cds) found material, suggestive of the soft tip from the steerable guide catheter, on the gripper arm of the cds, which may have contributed to the inability to grasp the leaflets.There was no additional information provided.

Manufacturer Narrative

(b)(4).Lot number: 60415u236, date of manufacture: 04/2016, expiration date: 04/30/2017, udi (b)(4).Lot number: 60509u107, date of manufacture: 05/2016, expiration date: 05/31/2017, udi (b)(4).The device was not returned for analysis.Since two lot numbers were reported, a review of the lot history record was performed for both lots which revealed no manufacturing nonconformities in either of the two lots.Additionally, a review of the complaint history did not indicate a lot-specific quality issue in the two sgc lots reported.As it was reported that the mitraclip device was used on the tricuspid valve, this incident is considered an off-label use of the device; however, the off-label use on the tricuspid valve does not appear to have contributed to the event.The mitraclip instructions for use states the mitraclip system is intended for reconstruction of the insufficient mitral valve through tissue approximation.The investigation was unable to determine a conclusive cause for the sgc cable break resulting in the inability to curve guide.It is possible that there were procedural interactions (e.G.Unintended curves on the device due to the tricuspid valve) which resulted in over-tensioning of the cables such that the cable broke; however, this cannot be confirmed.A definitive cause for the identified torn and detached soft tip material could not be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the 30-day medical device report, additional information was received that the steerable guide catheter (sgc) had a cable break.The sgc was in the atrium when the tip would not deflect with the turn of the plus/minus knob.The sgc was removed and replaced.This was a challenging case because of bad imaging conditions and a big gap between the leaflets.There was no difficulty with positioning the clip delivery system, there were no extreme curves on the steerable guide catheter (sgc) and there was no damage noted on the sgc soft tip after the procedure.There were two sgcs used for this patient, but it is unknown which of the two had the device issues.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: 5971010
• MDR Text Key: 55628988
• Report Number: 2024168-2016-06275
• 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: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SGC01ST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: CLIP DELIVERY SYSTEM