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

Catalog Number	635002
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient age, gender, weight, medical history, race, and ethnicity was not provided.Lot: the device lot number was reported by the complainant as (b)(4); however, this is not a valid lot number.Clarification has been requested.The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization of an unspecified aneurysm, the unspecified coil was being pressurized for detachment with a trufill dcs syringe ii (635002/unk) when a leakage was noted from the connection.The syringe was subsequently replaced.The same coil could be detached with the replacement syringe.The procedure was completed successfully without further incident.The surgery was not delayed due to the event.No patient complications occurred as a result of the event.The product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.No visible product damage was noted prior to and following the event.The syringe was prepped following ifu instructions.No unintended detachment was observed in the vessel or in the microcatheter.The user did not apply excessive force when handling the device.The device will not be returned for evaluation.No further information was provided.
Additional Manufacturer Narrative
(b)(4).Complaint conclusion: as reported by a healthcare professional, during a coil embolization of an unspecified aneurysm, the unspecified coil was being pressurized for detachment with a trufill dcs syringe ii (635002/96331305) when a leakage was noted from the connection.The syringe was subsequently replaced.The same coil could be detached with the replacement syringe.The procedure was completed successfully without further incident.The surgery was not delayed due to the event.No patient complications occurred as a result of the event.The product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.No visible product damage was noted prior to and following the event.The syringe was prepped following ifu instructions.No unintended detachment was observed in the vessel or in the microcatheter.The user did not apply excessive force when handling the device.No further information was provided.The trufill dcs syringe ii product was discarded by the complainant and is thus not available for evaluation.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.With the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the device history record review, there is no indication that the event is related to the manufacturing process of the unit.The exact cause of the event could not be conclusively determined; however, it is possible that procedural factors related to the connection of the devices may have contributed to the reported leakage.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: TRUFILL DCS SYRINGE II
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 7661625
• Report Number: 1226348-2018-00627
• Device Sequence Number: 1512715
• Product Code: HCG
• UDI-Device Identifier: 10886704029410
• UDI-Public: 10886704029410
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2018

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: 08/31/2019
• Device Catalogue Number: 635002
• Device Lot Number: 96331305
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 08/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1