MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE2 4MMX30MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number	ENF403000
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.The device lot number is not available / not reported.The expiration date of the device is not known.The device manufacture date is not known as the device lot number is not available / not reported.[conclusion]: the healthcare professional reported that the 4.0 mm dia x 30 mm with no tip enterprise®2 stent (enf403000 / lot#: unknown) became deployed in the microcatheter.There was no report of patient injury or complication.It was reported that the product is not available to be returned for evaluation.Based on complaint information, the device was not available to be returned for analysis.The device lot number was not available.The device history record (dhr) review could not be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.The lot number of the device is not known, therefore review of the device history record was not performed.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and/or device manipulation/interaction may have contributed to the reported failure.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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 1226348-2019-00863 and 1226348-2019-00864.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that the 4.0 mm dia x 30 mm with no tip enterprise®2 stent (enf403000 / lot#: unknown) became deployed in the microcatheter.There was no report of patient injury or complication.It was reported that the product is not available to be returned for evaluation.

• Brand Name: ENTERPRISE2 4MMX30MM NO TIP
• Common Device Name: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8470969
• Report Number: 1226348-2019-00863
• Device Sequence Number: 19161254
• Product Code: NJE
• UDI-Device Identifier: 10886704075387
• UDI-Public: 10886704075387
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2019

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 Catalogue Number: ENF403000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1