MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN CHEMOSITE; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	120021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively, the device wire was stuck in the puncture needle.There was no patient involved in this event.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) received one device.The visual inspection of the returned product noted no abnormalities.Pmv performed functional testing which included deploying and retracting the guide wire without difficulty.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, per additional information received, the operator inserted the guidewire into 18 gauge.However the guidewire was stuck and could not be able to pull out.

• Brand Name: CHEMOSITE
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mc dermott rd; north haven CT 06473
• MDR Report Key: 6893414
• Report Number: 1219930-2017-07395
• Device Sequence Number: 10904912
• Product Code: LJS
• UDI-Device Identifier: 10884521099371
• UDI-Public: 10884521099371
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2017

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: 02/29/2020
• Device Model Number: 120021
• Device Catalogue Number: 120021
• Device Lot Number: N5B0225X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Initial Date Received by Manufacturer: 09/02/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1