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

Catalog Number SGC01ST

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888)

Event Date 11/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Based on the information reviewed, the reported patient effect of hemorrhage (difficulty achieving hemostasis) was likely a result of procedural conditions as the steerable guide catheter (sgc) is inserted into the anatomy through an incision in the right groin and femoral vein; the reported anemia (drop in hemoglobin) was likely a secondary effect of the hemorrhage.The reported additional therapy/non-surgical treatment was a result of case specific circumstances, as a femstop was applied and hemostasis was achieved.The reported patient effect of bleeding/hemorrhage, as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This report is submitted for venous access site bleeding post procedure, requiring intervention.It was reported that on (b)(6) 2016, two mitraclips were successfully implanted, reducing the functional mitral regurgitation from grade 3+ to grade 1+.Post procedure, bleeding was noted at the femoral vein access site.There was difficulty achieving hemostasis and a drop in hemoglobin was noted.A femstop was applied and hemostasis was achieved.The event resolved without sequela.Reportedly, the patient is on chronic anticoagulation therapy.Per study physician, the event was not serious.There was no additional information 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: 6149371
• MDR Text Key: 61590469
• Report Number: 2024168-2016-08614
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648149559
• UDI-Public: (01)08717648149559(17)170531(10)10518U148
• 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: health professional,study
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: SGC01ST
• Device Lot Number: 10518U148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• 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
• Treatment: 2 IMPLANTED MITRACLIPS
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 88