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 Position (1467); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2015

Event Type  malfunction  

Manufacturer Narrative

The product will be returned for analysis, however, it has not been received.Additional information will be submitted within 30 days of receipt.(b)(4).Concomitant medical products and therapy dates: prowler14 microcatheter (details unknown), new coil (details unknown).

Event Description

It was reported by the hospital contact that during the coil embolization, the 1st coil (638mf0410/16011499) could not be shaped as expected.The microcatheter was prowler14 (details unknown).After adjustment, the coil stretched.The surgeon withdrew the coil and used a new one (details unknown) to complete the procedure.There was no report on the patient injury.The patient is male and (b)(6) years old, has an aneurysm with a size of 4.2*3.6 mm.It was initially reported that the product will be returned for analysis.An adequate continuous flush was maintained through the microcatheter.It was not reported if there was resistance during advancement of the coil through the microcatheter.It was not reported if there was resistance when the coil was repositioned.It was not reported if the coil was used like a guidewire to reposition the microcatheter.It is unknown if a one to one relationship between the coil and delivery tube was verified with fluoro prior to repositioning.There was no clinically significant delay in the procedure due to the event.

Manufacturer Narrative

It was reported by the hospital contact that during the coil embolization, the 1st coil (638mf0410/16011499) could not be shaped as expected.The microcatheter was prowler14 (details unknown).After adjustment the coil stretched.The surgeon withdrew the coil and used a new one (details unknown) to complete the procedure.There was no report on the patient injury.The patient is male and (b)(6), has an aneurysm with a size of 4.2*3.6 mm.It was initially reported that the product will be returned for analysis.An adequate continuous flush was maintained through the microcatheter.It was not reported if there was resistance during advancement of the coil through the microcatheter.It was not reported if there was resistance when the coil was repositioned.It was not reported if the coil was used like a guidewire to reposition the microcatheter.It is unknown if a one to one relationship between the coil and delivery tube was verified with fluoro prior to repositioning.There was no clinically significant delay in the procedure due to the event.A non-sterile orbit mini comp fill 4x10 tdl was received coiled 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 kinked at 16 and 53.5cm from the proximal end of hub.The introducer was received separated of the hypotube without damages.The support coil was inspected and no damages were noted on it.The gripper was inspected and it was found damage and the adhesion to the headpiece on it.The embolic coil was found stretched.The gripper and embolic coil were inspected under vision system; the gripper was found severely damage and the adhesion to the headpiece on it while the rest of the embolic coil was found separated of headpiece and stretched.The failure reported by the customer as ¿coil-positioning difficulty-poor conformability¿ could not be evaluated.¿coil - unraveled/stretched-during placement¿ was confirmed during analysis.However; 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 damage.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.

• 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: 5364598
• MDR Text Key: 35823541
• Report Number: 1226348-2016-00004
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K053197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 638MF0410
• Device Lot Number: 16011499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2013
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR