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

Catalog Number SGC01ST

Device Problems Leak/Splash (1354); Unstable (1667); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2016

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).Failure to follow steps/instructions - used after leak detected.The steerable guide catheter is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report that during preparation, the steerable guiding catheter (sgc) flush port was leaking.Leaks have the potential to cause or contribute to patient injury.It was reported that during preparation of the sgc, leaking was observed and it was noted that the 3-way taps to the sgc flush port were not able to be sealed.Multiple 3-way taps were tried, all with the same effect.Tape was used to seal the 3-way taps and the device was used successfully to treat functional mitral regurgitation (mr) with a grade of 4.One clip was implanted, reducing mr to 1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and investigated.The reported issues of loose/intermittent connection resulting in a leak were unable to be confirmed as proxy stopcocks were able to be securely attached.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.Reportedly, tape was used to seal a stopcock to the steerable guide catheter (sgc) flush port.The mitraclip system instructions for use warns: do not use if damage is detected.Use of damaged product may result in air embolism, vascular and/or cardiac injury.All available information was investigated and the reported loose/intermittent connection resulting in a leak is possibly related to variation in the non-abbott stopcocks used at the account; however, this cannot be definitively determined.The returned device analysis confirmed that the sgc flush port functioned as expected.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design 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: 5798621
• MDR Text Key: 49946334
• Report Number: 2024168-2016-04616
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: SGC01ST
• Device Lot Number: 60222U110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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: 80 YR
• Patient Weight: 75