MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PERITON CATH,120CM; STANDARD CATHETERS

Catalog Number 823045

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

Patient Problem Failure of Implant (1924)

Event Date 07/16/2021

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

2 of 2 reports.Other mfg report number: 3013886523-2021-00351.A physician reported a hakim peritoneal catheter was implanted to a patient via l-p shunt on unknown date.The ventral drainage deviated into the abdominal wall, resulting in abdominal wall edema and it was reconstructed using the same peritoneal catheter (mfg report number: 3013886523-2021-00351).However, abdominal wall edema has re- accumulated several days later.Then, the peritoneal catheter was removed and a new peritoneal catheter was placed on (b)(6) 2021.The patient was stable and recovering.No further information was provided by hospital.

Event Description

N/a.

Manufacturer Narrative

Unique device identification (udi): (b)(4).The hakim peritomeal catheter was returned for evaluation: failure analysis - the catheter was visually inspected and no defect was noted.The valve was leak tested and no leaks noted.The catheter was irrigated and no occlusion was noted.No root cause could be determined as the technician could not confirm any problem with the catheter at the time of investigation.The possible root cause for "abdominal wall edema re-accumulated" reported by the customer could be due to "cerebrospinal fluid (csf) not drained in appropriate cavity" and related to "user cuts the catheter too short" (surgical technique and/or user group experience).

Event Description

N/a.

Manufacturer Narrative

Updated fields:  g3, g6, h2, h3, h10.Additional information received indicated that the catheter was implanted to the patient via l-p shunt on (b)(6) 2021.The tip of the peritoneal catheter could be placed in the abdominal cavity, but abdominal wall edema re- accumulated several days later.Then, the peritoneal catheter was removed and a new peritoneal catheter was placed on (b)(6) 2021.

• Brand Name: HAKIM PERITON CATH,120CM
• Type of Device: STANDARD CATHETERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 12291392
• MDR Text Key: 265567228
• Report Number: 3013886523-2021-00359
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K944222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1