MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC TRUFILL DCS SYRINGE; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	635002
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial mdr is the only report being submitted for mfr report #1226348-2017-00129.(b)(4).The product will not be returned for analysis however a device history record review is currently being conducted and the results are not yet available.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
It was reported by a healthcare professional that a trufill dcs syringe (635-002/96331291) was not firmly connected at the luer connector during an emergency gastrointestinal bleed coil embolization procedure as the knob of the syringe could not be turned.The microcatheter was advanced to the target lesion and coil embolization began with a galaxy coil with the trufill dcs syringe (complaint product).The luer connector was not firmly connected during placement of the coil and the syringe was replaced with another one.The galaxy coil was then successfully detached.The patient was a male, age unknown.The patient¿s vessel level of tortuousness and calcification were also unknown.No report of other devices used during the procedure is available.There was no damage noted to the syringe prior to use and it was filled with saline from a dedicated source.The procedure was successfully completed without further issues and there was no delay in procedure.There was also no patient injury/complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.The product is not available for the investigation.No further information is available.
Additional Manufacturer Narrative
This final mdr will be the only report submitted for manufacturer report #1226348-2017-00129.Conclusion: based on the information, the event could not be confirmed.The product was not returned for analysis; however, a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.

• Brand Name: TRUFILL DCS SYRINGE
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• MDR Report Key: 6794370
• Report Number: 1226348-2017-00129
• Device Sequence Number: 16584452
• Product Code: HCG
• UDI-Device Identifier: 10886704029410
• UDI-Public: (01)10886704029410(17)190228(10)96331291
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 635002
• Device Lot Number: 96331291
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2017
• Supplement Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 09/08/2017
• Patient Sequence Number: 1