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

Model Number UNKNOWN SPACEMAKER BALLOON

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

Patient Problems Rupture (2208); Post Operative Wound Infection (2446); Radiation Exposure, Unintended (3164); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(conversion, exthsp, rupture of scarred peritoneum) title: precostal top-down extended totally extraperitoneal ventral hernia plasty (etep): simplification of a complex technical approach.Source: hernia (2020) 24:527¿535 published online: 27 november 2019 if information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed from october 2017 to february 2019, during precostal top-down extended totally ext raperitoneal ventral hernia plasty (etep), one conversion to transabdominal, partially extraperitoneal plasty (tape) was required after an extensive rupture of the scarred peritoneum in the right lower abdomen.The antiadhesive implant was positioned intraperitoneally above the peritoneal defect and extraperitoneally into the space of retzius after urinary bladder mobilization below the defect.One patient was readmitted to the ward on postoperative day-5 because of a subcutaneous infection at the site of a precostal trocar.The wound was reopened, flushed and successfully managed with open wound management.Another patient presented with clinical signs of small bowel obstruction on postoperative day-4.A ct-scan revealed a herniation of small bowel into the abdominal wall.The case was managed laparoscopically.Exploration revealed an entrapment of bowel between a ruptured peritoneal suture in the crossover zone and the mesh implant.The bowel was reduced and the defect covered by intraperitoneal composite mesh placement.

• Brand Name: UNKNOWN SPACEMAKER BALLOON
• 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: 10292051
• MDR Text Key: 199436225
• Report Number: 2647580-2020-02208
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN SPACEMAKER BALLOON
• Device Catalogue Number: UNKNOWN SPACEMAKER BALLOON
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2020
• 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): Required Intervention