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 11/22/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This is filed to report that during use with the steerable guiding catheter (sgc), the stopcock would not stay tightened on the sgc flush port and if were to reoccur in the patient anatomy, has the potential to cause or contribute to patient injury.It was reported that after the steerable guiding catheter (sgc) was prepared for use, the femoral skin was dilated, and the sgc was advanced, but it was found that the stopcock would not stay tightened on the sgc flush port.Three separate stopcocks were attempted, but would not tighten.The sgc was never inserted into the anatomy, and was replaced.A new sgc was successfully used with one of the previously attempted stopcocks.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the steerable guide catheter (sgc) was returned and investigated.The reported loose/intermittent connection was unable to be confirmed.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.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: 6183488
• MDR Text Key: 62958851
• Report Number: 2024168-2016-08995
• 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: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60802U230
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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