MAUDE Adverse Event Report: MEDERI THERAPEUTICS INC MEDERI STRETTA CATHETER; ELECTROSURGICAL DEVICE

Model Number	175-5580
Medical Device Problem Codes	Nonstandard Device (1420); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A company field representative noted a product problem and it was confirmed by the company through inspection of internal inventory that the problem could result in a breach in the packaging.

• Brand Name: MEDERI STRETTA CATHETER
• Common Device Name: ELECTROSURGICAL DEVICE
• Manufacturer (Section D): MEDERI THERAPEUTICS INC; 800 connecticut avenue; 1e01; norwalk CT 06854
• MDR Report Key: 6456594
• Report Number: 3007729452-2017-00002
• Device Sequence Number: 476752
• Product Code: GEI
• UDI-Device Identifier: 00856219002294
• UDI-Public: (01)00856219002294(17)181025(10)299ST-16
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K000245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Replace,Inspection,Recall
• Type of Report: Initial
• Report Date (Section B): 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 01/25/2018
• Device Model Number: 175-5580
• Device Catalogue Number: 175-5580
• Device Lot Number: 299ST-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2017
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1