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

Catalog Number 82-3045

Device Problem Material Integrity Problem (2978)

Patient Problem Tissue Damage (2104)

Event Date 09/05/2018

Event Type  Injury  

Manufacturer Narrative

Udi -- (b)(4).The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported by the affiliate that after implantation of a peritoneal catheter, the catheter was ligated to block flow of csf.After the ligation was done, the physician tried to attach a new catheter to the old catheter with a connector; however, the old catheter was ruptured.The valve was implanted to the patient via lp-shunt; however, the doi and initial setting were unknown.The surgeon commented that he/she didn't pull the catheter.No further information was provided by hospital.The product will be returned.

Manufacturer Narrative

The catheter was received for evaluation.The 20mm of catheter was visually inspected: one end was clean cut and the other was a jagged.Small holes were noted in the catheter by the jagged end.A review of manufacturing records could not be performed, as no lot number has been provided.The root cause is likely due to a sharp object coming in contact with the catheter.As noted in the ifu, silicone has a low tear/cut resistance.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: HAKIM PERITONEAL CATHETER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7980855
• MDR Text Key: 124327065
• Report Number: 1226348-2018-10734
• 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
• Report Date: 09/27/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 82-3045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Initial Date Manufacturer Received: 09/27/2018
• Initial Date FDA Received: 10/18/2018
• Supplement Dates Manufacturer Received: 12/03/2018
• Supplement Dates FDA Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1