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

Model Number	82-1697
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/27/2018
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
As reported by the affiliate, that a vps valve system was blocked post implantation.The device was removed and the physician did an intraoperative check, the holter inline shunt filter was clogged.The physician had to use a syringe containing water was used to unclog it.
Additional Manufacturer Narrative
Udi: (b)(4).The device was returned for evaluation.The filter was visually inspected; no defects noted.The filter was irrigated, no occlusions noted.A review of manufacturing records found the device conformed to specification prior to distribution.Based on the results of the investigation, the reported issue could not be confirmed.The device functioned as intended.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CODMAN HOLTER SHUNT FILTER
• 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: 7735870
• Report Number: 1226348-2018-10527
• Device Sequence Number: 805434
• Product Code: JXG
• UDI-Device Identifier: 10886704040767
• UDI-Public: (01)10886704040767(10)CVDCVD
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,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: 03/31/2021
• Device Model Number: 82-1697
• Device Catalogue Number: 82-1697
• Device Lot Number: CVDCVD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• 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