MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC SPACEMAKER PREPERITONEAL DIST BALLOON; SPACEMAKER BALLOON

Model Number OMSPDB1000

Device Problem Material Rupture (1546)

Patient Problem Rupture (2208)

Event Type  Injury  

Event Description

Citation: chow, p., su, y., + chen, y.(2013).A rare complication from total extraperitoneal (tep) laparoscopic inguinal hernia repair: bladder rupture associated with a balloon dissector.{i}hernia,{/i} {i}17{/i}, 797-799.Procedure: tep herniorrhaphy according to the reporter: a (b)(6) man underwent tep inguinal hernia repair.Bladder rupture was noted after balloon dissection.The defect was sutured, and the hernia was repaired under laparoscopy.Cystoscopy showed the site of injury at anterior bladder neck.At the beginning of the operation, a para-umbilical incision was made, and a 5-12mm trocar was introduced into the preperitoneal space and advanced to the pubic bone under direct vision through a visiporttm.The trocar was then replaced with a balloon dissector ((b)(4), covidien), which was inflated with a manual pump.As the balloon inflated, a somewhat limited distension was noted in the mid-lower abdomen, while the bilateral parts were distended normally.Upon further pumping, the balloon popped and the abdomen flattened.The balloon dissector was removed, and a trocar was set as a camera port.Two additional working ports were set in the bilateral lower abdomen, between the umbilicus and anterior superior iliac spines, about 5 cm from the umbilicus, and the bladder wall was repaired laparoscopically with continuous suture.A cystoscopy was then performed, revealing a well-distended bladder with the suture at the bladder neck.In our case, bladder rupturewas noted after the balloon popped.The site of the laceration was at the anterior bladder neck.The pop may have resulted from an excessive advancement of the dissector toward the pubis during the dissection and in its turn the asymmetrical expansion of the balloon.

Manufacturer Narrative

(b)(4).

• Brand Name: SPACEMAKER PREPERITONEAL DIST BALLOON
• Type of Device: SPACEMAKER BALLOON
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4406095
• MDR Text Key: 15316494
• Report Number: 2647580-2015-00019
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K935426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OMSPDB1000
• Device Catalogue Number: OMSPDB1000
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR