MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX; CNV DCS ORBIT (HCG)

Catalog Number 638MF0410

Device Problems Difficult to Remove (1528); Stretched (1601); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2015

Event Type  malfunction  

Manufacturer Narrative

Udi# (b)(4).Initial reporter: (b)(6).The device will be returned for analysis, but it has not been received for analysis.Additional information will be submitted within 30 days of receipt.

Event Description

During the stent assist coil embolization procedure the orbit mini comp fill 4x10 tdl coil (638mf0410/16080557) could not be advanced to aneurysm.The surgeon decided to remove the coil but it was stretched.The surgeon had to remove the mc and coil.And then he reshaped the mc and changed the new coil to complete.There was no report on patient injury.The target site was the ophthalmic aneurysm with 4.8*5.9mm.The microcatheter used with the coil was a prowler 14, and a constant and dedicated saline source was used at all times.Other than the reported event, no other damages were noticed on the device (kink, bend, fracture, separate, etc.), and the coil remained attached to the delivery system.No further information was available.

Manufacturer Narrative

The patient is female and (b)(6) years old, had ophthalmic aneurysm with 4.8*5.9mm.During the stent assist coil embolization procedure the orbit mini comp fill 4x10 tdl coil (638mf0410/16080557) could not be advanced to aneurysm.The surgeon decided to remove the coil but it was stretched.The surgeon had to remove the mc and coil.And then he reshaped the mc and changed the new coil to complete.There was no report on patient injury.The microcatheter used with the coil was a prowler 14, and a constant and dedicated saline source was used at all times.Other than the reported event, no other damages were noticed on the device (kink, bend, fracture, separate, etc.), and the coil remained attached to the delivery system.After the microcatheter was reshaped it was utilized to complete the procedure.The shaping mandrel was used to reshape the tip and no damages were noticed after reshaping was completed.The microcatheter is not going to be returned for analysis.No further information was available.A non-sterile orbit mini comp fill 4x10 tdl was received coiled in dispenser inside pouch of original packaging inside of a plastic bag.No damages were noted on the hub.The hypotube was inspected and it was found severely kinked and appears that it was kinked before it was separated.The introducer was received unzipped and it was found damage.The support coil was inspected and it was found without damage.The gripper was found elongation condition and residues of dry blood were found on it.The soldered section of the headpiece was found in the gripper.The rest of the embolic coil was found separated and stretched.The gripper and headpiece were inspected under microscope; elongation condition and residues of dry blood were found on it.The soldered section between headpiece and the coil loops was not fractured so this means that the solder had a good adhesion to the headpiece.The rest of the embolic coil was found stretched.The od from the delivery tube was measured and was found within specification.The functional test could not be performed due to device condition received.The review of lots 16080557 and 16051584 presented no issues that were considered potentially related to the reported complaint.The failure reported by the customer as ¿detachable coil delivery system (dcs)- resistance/friction-during advancement ¿could not be evaluated due to conditions of the device received.The failure reported by the customer as ¿coil- unraveled/stretched¿ was confirmed during the microscope analysis.The failure reported by the customer as ¿coil- withdrawal difficulty-into microcatheter¿ could not be evaluated.The condition of the embolic coil was apparently caused by applying excessive force on it but it could not be conclusively determined.However; these defects could not be related to the manufacturing process and procedural factors appear to have contributed to have these damages.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process.Additionally inspections are in place that prevents this kind of failures from leaving the facility.Therefore no corrective action will be taken at this time.

Manufacturer Narrative

Additional information indicated that after the microcatheter was reshaped it was utilized to complete the procedure.The shaping mandrel was used to reshape the tip and no damages were noticed after reshaping was completed.The microcatheter is not going to be returned for analysis.Additional information will be submitted within 30 days of receipt.

• Brand Name: TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX
• Type of Device: CNV DCS ORBIT (HCG)
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: kimberly soter ; 325 paramount dr; raynham, MA 02767 ; 5089777396
• MDR Report Key: 5089823
• MDR Text Key: 26247536
• Report Number: 1226348-2015-00033
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K053197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: 638MF0410
• Device Lot Number: 16080557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR