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

Catalog Number SGC0101

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The steerable guiding catheter was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that during device preparation, the three-way stopcock was attached to the flush port on the steerable guide catheter (sgc); however, when the sgc was turned upside down to advance on the guide wire, the stopcock fell off.In order to use the device, sutures and tape were used to secure the stopcock in place.The sgc was used in the mitraclip procedure without further incident.Two clips were successfully implanted and mitral regurgitation (mr) was reduced from grade 4 to 2.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned and investigated.The reported loose/intermittent connection was unable to be confirmed.The returned stopcock, as well as a proxy stopcock, were tightened onto the sgc flush port with no issues.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.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 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 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: 6062566
• MDR Text Key: 58769284
• Report Number: 2024168-2016-07369
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60308U216
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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: 50 YR
• Patient Weight: 51