MAUDE Adverse Event Report: US SURGICAL PUERTO RICO UNKNOWN PROTACK; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number UNKNOWN PROTACK

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

Patient Problem Cardiac Tamponade (2226)

Event Date 03/23/2012

Event Type  Injury  

Manufacturer Narrative

Title: paraesophageal hernia repair followed by cardiac tamponade caused by protacks.Source: the society of thoracic surgeons.Ann thorac surg 2012; 94: e87¿9).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study performed on 2012, a patient with comorbid arterial hypertension suffering from gastroesophageal reflux disease and stage three paraesophageal hernia was qualified to undergo a laparoscopic 360-degree nissen operation with mesh reinforcement in a surgical ward.A case of cardiac tamponade occurred and was suggested to be a cause of the tacker.Frequently, esophageal hiatus requires additional reinforcement with synthetic mesh that can be sutured or stapled.Among possible complications of such procedures are: postoperative leak, recurrent hernia, wound infection, esophageal erosion, and migration of mesh.At the third postoperative day, the patient collapsed with signs of acute heart failure and low output syndrome secondary to cardiac tamponade.On admission, the patient was anuric, anemic, acidotic, and the blood pressure was stabilized with the use of high-dose catecholamines.Echocardiography showed a layer of up to 3 cm of fresh blood with clots in the pericardium.On emergency sternotomy, approximately 1500 mm3 of hemolyzed blood with clots was retrieved from pericardial sac.Two autosutures tacks penetrating into the pericardial sac were noted.

• Brand Name: UNKNOWN PROTACK
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8800677
• MDR Text Key: 151417083
• Report Number: 2647580-2019-03722
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PROTACK
• Device Catalogue Number: UNKNOWN PROTACK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/17/2019
• 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 Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 40