MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE2 4MMX39MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number	ENF403912
Medical Device Problem Code	Flushing Problem (1252)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient age, gender, weight, medical history, race, and ethnicity was not provided.It was not reported if the product is available for evaluation and testing.Additional information will be submitted within 30 days of receipt.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.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, the introducer sheath of the enterprise2 (enf403912/10817885) stent delivery system did not flush properly.The introducer was advanced into the rotating hemostatic valve (rhv) and flushed, but air bubbles were trapped inside of the introducer sheath.There was no report of consequence or impact to the patient.The product will be returned for analysis.No further information was provided.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Complaint conclusion: as reported by a healthcare professional, the introducer sheath of the enterprise2 (catalog: enf403912/lot: 10817885) stent delivery system did not flush properly.The introducer was advanced into the rotating hemostatic valve (rhv) and flushed, but air bubbles were trapped inside of the introducer sheath.There was no report of consequence or impact to the patient.Multiple attempts to obtain additional information were unsuccessful.A non-sterile enterprise device was received inside of a pouch.The delivery wire was inspected and no damage was observed.Residues of dried saline solution were observed inside of the introducer.The stent was found in its original position with residues of dried saline solution.The received device was inspected under microscope and the residues of dried solution in the stent and introducer were confirmed.Functional analysis was performed.Despite the residues of dried saline solution found inside of the introducer, the device could be purged.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.The reported customer complaint ¿enterprise system- inability to purge¿ could not be confirmed.Neither the device history record review nor the product analysis suggest that the reported failure could be related to the manufacturing process of the unit.Based on the limited information available for review, it is possible that procedural and handling factors may have contributed to the event.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: ENTERPRISE2 4MMX39MM
• Common Device Name: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 7438604
• Report Number: 1226348-2018-00552
• Device Sequence Number: 1030364
• Product Code: NJE
• UDI-Device Identifier: 10886704075394
• UDI-Public: 10886704075394
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: H60001
• 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): 03/29/2018

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: 02/28/2020
• Device Catalogue Number: ENF403912
• Device Lot Number: 10817885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1