MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM PERITONEAL CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Model Number	82-3045
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	07/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
It was reported that a medos peritoneal catheter was leaking post implantation and there was revision of the device.The valve was implanted to the patient via l-p shunt, date of implant and initial setting are unknown.At the outpatient department, the patient complained of feeling sick.Leakage of csf was confirmed at 1 cm from the distal connection on the catheter by an image.The revision surgery was performed, and cracked part of the catheter was cut off and then the catheter was re-connected.No further information was provided by hospital.The product will not be returned to your site.
Additional Manufacturer Narrative
Udi : (b)(4).The device was returned for evaluation.The 18mm of catheter (in 2 parts) was visually inspected, cut/tear was noted.A review of manufacturing records found that the device confirmed to specification when released to stock.Based on the evaluation of the device, the root cause is likely due to user handling of the device.As noted in the ifu, silicone has a low cut/tear resistance.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: HAKIM PERITONEAL CATHETER
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle, CH240 0; SZ CH2400
• MDR Report Key: 7736568
• Report Number: 1226348-2018-10531
• Device Sequence Number: 19477930
• Product Code: JXG
• UDI-Device Identifier: 10886704041276
• UDI-Public: (01)10886704041276(10)176937
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K944222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 82-3045
• Device Catalogue Number: 82-3045
• Device Lot Number: 176937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR