MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC; PERCUTANEOUS CATHETER

Catalog Number UNK-CES GUIDING CATHETERS

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

Patient Problem Foreign Body Reaction (1868)

Event Type  Injury  

Manufacturer Narrative

This is two of two initial /final mdr reports being submitted for this complaint, with associated manufacture report numbers of 1058196-2016-00070.Exact date of event unknown.Date of event reported as (b)(6) 2016 for the foreign body reaction by the contact at the user facility.Unknown part number, all 3 attempts to obtain product were unsuccessful, udi unavailable.Part number and lot number unknown, manufacturing date and expiration date unknown.Date of procedure is unknown, product is catheter not implanted or explanted.The root cause of the reported product issue cannot be determined.The product was not returned for analysis and a device history record review cannot be completed because the lot for the product is unknown.

Event Description

As reported by a health care professional, after a successful aneurysm intervention including access, a stent and coils, the patient developed a rare form of foreign matter reaction in the brain.The event occurred after the procedure.Patient outcome is unknown and date of the actual procedure is unknown.No additional information is available at this time.

Manufacturer Narrative

This is follow-up mdr report being submitted for this complaint, with associated manufacture report numbers of 1058196-2016-00070.Details for patient's foreign matter reaction added to the event description "granulomatose angiitis".

Event Description

As reported by a health care professional, after a successful aneurysm intervention including access, a stent and coils, the patient developed a rare form of foreign matter reaction identified as granulomatose angiitis in the brain.No additional information is available at this time.The event occurred after the procedure.

• Type of Device: PERCUTANEOUS CATHETER
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: karen anigbo ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 5088288374
• MDR Report Key: 5534221
• MDR Text Key: 41425122
• Report Number: 9616099-2016-00155
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K000715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CES GUIDING CATHETERS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention