MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A.; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number UNKNOWN PERITONEAL CATHETER

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

Patient Problem Peritonitis (2252)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Title wang¿s forceps-assisted percutaneous insertion and fixation of peritoneal dialysis catheter source artificial organs, volume 42, 2018 (728-735) article number: 7 date of publication: 30 march 2018 this device has been reported as a general medtronic dialysis product, but no further information was provided.A variety of fda product codes are associated with this group of products, and the specific code cannot be identified with the information available.The most common fda product code for this type of device has been added to the product information within this report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, post-operatively, there was a study about the use of a novel technique termed ¿wang¿s forceps-assisted catheter insertion and fixation,¿ on 20 esrd patients.From january 2016 to january 2017, a total of 42 patients with esrd preferring to be treated with peritoneal dialysis were included.Among them, 22 patients received the wang¿s forceps-assisted open surgical catheter placement and fixation (o group) and 20 patients received wang¿s forceps-assisted percutaneous catheter placement and fixation (p group).The conventional catheter insertion set included a coiled tenckhoff catheter, the catheter matched stylette, and the tunnel needle.The fixation toolkit included the wang¿s forceps, y-tec needle, serial dilators with gauge ranging from 14fr, 16fr, 18fr, 20fr, 22fr, and 24fr, the 24fr dilator matched split sheath, guide wire, and the veress needle.The mean operating time in the p group was 29.263.53 min, which was significantly less than that in the o group of 88.5665.88 min (p<.05), indicating the procedure of percutaneous placement was simple, easy, and fast to perform.It is worth noting that patients receiving the percutaneous catheter placement suffered less operating pain than patients receiving open surgical catheter placement.Moreover, as a minimally invasive approach, wang¿s forceps-assisted percutaneous placement of catheter left nearly no scar on the patients¿ abdominal wall, while in the patients of o group the skin scar was obviously visible.No catheter related complications of leakage, catheter malposition, nor bowel perforation occurred in either the o group or p group.One patient in the o group encountered two episodes of peritonitis, while no infection happened in the p group.

• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 7874192
• MDR Text Key: 120189365
• Report Number: 3009211636-2018-00306
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PERITONEAL CATHETER
• Device Catalogue Number: UNKNOWN PERITONEAL CATHETER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2018
• 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