MAUDE Adverse Event Report: AV-TEMECULA-CT PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

Catalog Number 12673-03

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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

It was reported that suture placement in the calcified right common femoral artery was achieved with two proglide devices using the pre-close technique via 6f sheath prior to a abdominal aortic aneurysm (aaa) procedure.The sutures of the two proglide device were successfully pre-placed without incident; however, after pre-placing the sutures of the second proglide "all of the sudden" there was uncontrolled bleeding from the access site.A cut down was performed getting better access to the artery and there was no evidence noted of a vessel perforation.The sheath was upsized to 12f sheath and the aaa was completed.After the aaa procedure, hemostasis was attempted with the sutures from the two proglide devices; however, there was still bleeding from the access site.The cut down was extended and a perforation was found near the inguinal ligament.The perforation was surgically repaired and hemostasis was achieved with surgical suturing.The level of anesthesia was not changed as the patient was already under general anesthesia for the aaa procedure.The patient had a drop in blood pressure during the procedure due to the blood loss from the perforation.A blood transfusion and medications were given to counteract the dropping of the blood pressure.A clinically significant delay reportedly occurred in the procedure.Additionally, the patient required prolonged hospitalization.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the treatment(s) appears to be related to circumstances of the procedure.The patient effects are potential adverse events.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
• Type of Device: SUTURE MEDIATED CLOSURE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7625814
• MDR Text Key: 111905337
• Report Number: 2024168-2018-04766
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12673-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2018
• 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: SHEATH: 6F, 12FHEPARIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 76