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U.S. Department of Health and Human Services

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

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CODMAN & SHURTLEFF, INC. HAKIM PERITONEAL CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
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.
 
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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 Key7980855
MDR Text Key124327065
Report Number1226348-2018-10734
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K944222
Number of Events Reported1
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 Number82-3045
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2018
Initial Date Manufacturer Received 09/27/2018
Initial Date FDA Received10/18/2018
Supplement Dates Manufacturer Received12/03/2018
Supplement Dates FDA Received12/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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