MAUDE Adverse Event Report: AESCULAP, INC. PROGAV 2.0; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Lot Number 20029290

Device Problem Break (1069)

Patient Problems Tissue Damage (2104); Constipation (3274)

Event Date 05/18/2017

Event Type  malfunction  

Event Description

The patient had surgery for a shunt malfunction mid-may due to kidney, ureters, and bladder x-ray (kub) showing that his existing peritoneal shunt had a break in it distally.The existing shunt was placed 22 days earlier.Course of action was laparoscopic distal shunt revision.The patient had a cerebrospinal fluid (csf) shunt placed initially.A kub test was ordered sometime after that and it was discovered upon interpretation that the distal shunt was broken into.Patient was advised to see his neurosurgeon for followup.Patient added on to or schedule on mid-(b)(6) for laparoscopic distal shunt revision.Shunt was removed and new shunt inserted.Indications for operation: the patient is a (b)(6) year-old male with spina bifida, shunted hydrocephalus who was noted to be having constipation.Mom then took him to his gi physician, who ordered a kub and on the kub, it was noted that he had a break in his distal shunt which was just placed the month before.I therefore felt that he needed to undergo a distal shunt revision.We opted for laparoscopic given that he had to get out his retained catheter under direct visualization.Description of operation: after obtaining informed consent, patient was brought into the operating room.Patient had smooth induction performed.Patient was placed in the supine position.The abdomen was prepped and draped in usual sterile fashion.A 1 cm incision was made over a prior incision just below the twelfth rib on the right side using a 15 blade scalpel, carried down to the fascia using electrocautery.I then attempted to retrieve the portion of the catheter that had broke; however, it seemed to have retracted further up.I, therefore, made a small 0.3 cm neck incision just over the catheter using a 15 blade scalpel.The catheter was then retrieved and cut and a straight connector was then connected to the catheter and secured using a 2-0 silk tie.Physician then placed a trocar after insufflating the abdomen and a camera and this incision was done through the umbilicus.He then placed the trocar through the other incision that was previously made and was able to retrieve the abdominal portion of the catheter.Please see his dictation note for further details for this procedure.We then connected the bactiseal catheter to the straight connector as well, which was also connected to the previous catheter.There was noted to be great csf flow.I then was able to connect this using a 2-0 silk tie.I then, through the peel-away sheath, the other dr.Placed the catheter into the peritoneum under direct visualization.All the trocars were then removed as well as the peel-away sheath.The wounds were copiously irrigated with bacitracin irrigation and then we began our closures.The fascial layer was closed using 4-0 vicryl, subcutaneous layer was closed using 4-0 vicryl, and the skin was closed using dermabond.Mepilex dressing was then placed over each incision.The patient was extubated, taken to pacu in stable condition.There were no complications.We did also send the catheter back to the manufacturer given that it was a brand new catheter that had broken in half.

• Brand Name: PROGAV 2.0
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): AESCULAP, INC.; 3773 corporate pkwy.; center valley PA 18034
• MDR Report Key: 6739809
• MDR Text Key: 80910763
• Report Number: 6739809
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Lot Number: 20029290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR